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Tan, J.Y., Molassiotis, A., Wang, T., & Suen, L.K. (2014). Current evidence on auricular therapy for chemotherapy-induced nausea and vomiting in cancer patients: A systematic review of randomized controlled trials. Evidence-Based Complementary and Alternative Medicine, 2014, 430796. 

Purpose

STUDY PURPOSE: To assess the evidence for the therapeutic effects of auricular therapy (AT) on chemotherapy-induced nausea and vomiting (CINV) in patients with cancer 
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL,AMED, PsycINFO, Thomson Reuters Web of Science, Science Direct, China National Knowledge Infrastructure (CNKI), WanFang Data, Chinese Scientific Journal Database (VIP), and Chinese Biomedical Literature Database (CBMdisc)
 
KEYWORDS: Auriculotherapy, acupuncture, ear, auricular therapy, ear acupunctur, nausea, vomiting, antiemetic, chemotherapy, antineoplastic agent, and neoplasms
 
INCLUSION CRITERIA: (a) Randomized controlled trials, (b) patients with cancer and acute or delayed nausea and vomiting after receiving chemotherapy, and (c) trials comparing AT with or without antiemetic medications to one or more of the following: sham AT control, concomitant antiemetic medications, usual care, waiting-list control, or no treatment
 
EXCLUSION CRITERIA: Clinical case reports and case series, nonrandomized controlled trials, and other uncontrolled clinical trials

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,056 records were obtained. 166 duplicated items were removed, and another 809 items were excluded after browsing their titles and abstracts. Ultimately, 21 studies were eligible for analysis.
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The study selection was performed by two independent reviewers.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 21
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,713
  • KEY SAMPLE CHARACTERISTICS: Patients were aged 6–80 years and were recruited from inpatient settings and outpatient clinics. The average sample size was 81 patients. The studies focused on a variety of malignancies including breast cancer, lung cancer, leukemia, gastrointestinal cancer, and (in one study) pediatric cancer.

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Pediatrics and elder care

Results

Among all trials:
  • Effective rate of AT with acute CINV: 44.44%–93.33% intervention group; 15%–91.67% control group
  • Effective rate of AT with delayed CINV: 62.96%–100% intervention group; 25%–100% control group
  • Studies comparing antiemetics versus antiemetics plus AT found the intervention group more effective. Intervention group: 54.62%–100%; control group 34.38%–100%
  • Four studies investigated the effect of auricular acupressure on either acute or delayed CINV. There was no concordance of results. Some studies showed more improvement in acute, some in delayed, and some showed no difference.
  • Three studies that included information about the performance statuses of patients using the Karnofsky Performance Status (KPS) index demonstrated a favorable effect on KPS scores in the intervention group compared to the control group.
  • Twenty studies did not monitor patient compliance with the intervention, and the length of pressing acupuncture points varied from 30 seconds to 5 minutes.

Conclusions

This review was a helpful starting point to spur more research on the use of AT for the management of CINV. There was significant heterogeneity among the trials, but there appeared to be encouraging results for the use of AT to justify additional research. To better answer the question about AT's benefit, well-designed, randomized, controlled trials will be needed. From the information presented, it appears that AT may have a role in the management of delayed CINV, which can be challenging to manage and very troublesome for patients.

Limitations

The investigators were only able to evaluate English and Chinese studies, which may have prevented the review of other studies such as Korean trials.

Nursing Implications

Encouraging results were identified about the adjunct use of AT for CINV, but this review demonstrated the need for well-designed trials incorporating AT with antiemetic regimens for acute and delayed CINV. The trials need to incorporate standard AT points, standard pressing length at each point, and a standard CINV assessment scale. Patient compliance also should be assessed and documented.

Print

Tam, K.W., Chen, S.Y., Huang, T.W., Lin, C.C., Su, C.M., Li, C.L., . . . Wu, C.H. (2015). Effect of wound infiltration with ropivacaine or bupivacaine analgesia in breast cancer surgery: A meta-analysis of randomized controlled trials. International Journal of Surgery, 22, 79–85. 

Purpose

STUDY PURPOSE: To evaluate the efficacy of anesthetic wound infusion for analgesia in women undergoing breast cancer surgery

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: PubMed, EMBASE, Cochrane Library, SCOPUS, Clinicaltrials.gov
 
INCLUSION CRITERIA: Randomized, controlled trials evaluating wound infiltration with local anesthetics
 
EXCLUSION CRITERIA: Not involving partial or modified radical mastectomy

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 759
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane risk of bias evaluation

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 13
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,150
  • SAMPLE RANGE ACROSS STUDIES: 30–238 patients
  • KEY SAMPLE CHARACTERISTICS: All had undergone breast cancer surgery

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

Meta-analysis was done to compare groups for pain severity at 1, 2, 12, and 24 hours. Meta-analysis showed no difference between groups. Analysis did not show any statistically significant difference in analgesic consumption. No adverse events were identified.

Conclusions

Findings did not show significant differences in pain outcomes between those given local anesthetic wound infiltration and those given standard care.

Limitations

  • High heterogeneity
  • Low sample sizes

Nursing Implications

Findings suggest that infusion of ropivacaine or bupivacaine following breast cancer surgery did not provide significant clinical benefit in terms of pain severity or postoperative analgesic needs. Individual studies showed mixed results, and high heterogeneity existed across studies, a limitation of this analysis.

Print

Takigawa, C., Goto, F., Tanda, S., Shima, Y., Yomiya, K., Matoba, M., . . . Eguchi, K. (2015). Breakthrough pain management using fentanyl buccal tablet (FBT) in combination with around-the-clock (ATC) opioids based on the efficacy and safety of FBT, and its relationship with ATC opioids: Results from an open-label, multi-center study in Japanese cancer patients with detailed evaluation. Japanese Journal of Clinical Oncology, 45, 67–74.

Study Purpose

To assess the safety and efficacy of fentanyl buccal tablets (FBT) in breakthrough pain (BTP) management when given in combination with around-the-clock (ATC) opioids and to explore the influence of dose adjustments on breakthrough pain management

Intervention Characteristics/Basic Study Process

Before the maintenance phase, the FBT dose that was successful in providing sufficient pain relief without producing unacceptable adverse events was identified by titration. During the 12-week maintenance phase, the FBT dose was administered for BTP episodes. The successful dose ranged from 100–800 ug for patients who received an ATC opioid dose of 60–1,000 mg per day of oral morphine and from 50–800 ug for those who received from 30– < 60 mg per day of oral morphine equivalents. Patients were allowed to take additional supplemental medications including FBT when no pain relief was perceived by 30 minutes after FBT administration. FBT or ATC opioid doses could be changed if additional supplemental medications (including FBT) were frequently administered for BTP episodes or if there were five or more BTP episodes per day. FBT could be administered eight times per day for a maximum of six BTP episodes per day. Prestudy medications were given for the seventh or more BTP episode in a day of if the BTP episode occurred within four hours after a FBT administration.

Sample Characteristics

  • N = 82  
  • AGE = 20 years and older
  • MALES: 60%, FEMALES: 40%
  • KEY DISEASE CHARACTERISTICS: Patients with cancer-related pain caused by solid or hematologic tumors and a life expectancy of three months or longer. Participants had to receive ATC opioid regiments to control their pain for at least one week prior to enrollment and had to experience one to four BTP episodes per day that had been controlled with supplemental medications.  
  • OTHER KEY SAMPLE CHARACTERISTICS: Ability to evaluate pain in a self-recording diary; performance status grades 0–2 based on the Eastern Cooperative Oncology Group (ECOG) guidelines; exclusion included diseases or symptoms that could affect safety, oral conditions that could interfere with FBT application, clinical disorders that could compromise data collections (e.g., psychological), or concomitant medications including monoamine oxidase inhibitors, narcotic antagonist analgesics, narcotic antagonists and drugs administered for other clinical trials

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Not specified    
  • LOCATION: 34 sites in Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Palliative care 

Study Design

Open-label study

Measurement Instruments/Methods

  • Pain intensity, pain relief, a global medication performance assessment, and an overall impression of FBT treatment were evaluated with each FBT administration.
  • Safety included vital signs, arterial oxygen saturation, and the frequency and severity of each adverse event.

Results

Forty-one patients completed the 12-week maintenance phase. A major reason for discontinuation was adverse events. No patients discontinued because of a lack of treatment efficacy. Treatment-related adverse events were reported by 37% of patients during the maintenance phase. The most common adverse events were somnolence (16%) and nausea (10.7%). Five deaths occurred during the study, none of which were related to FBT. Both the FBT and ATC opioid doses gradually increased over time from the beginning of the maintenance phase. The breakthrough FBT dose was changed in 42 patients (56.8%). The ATC opioid dose was changed in 50 patients (67.5%).

Conclusions

FBT has sustained analgesic effect and was well tolerated. Quality of life was reported to improve with stable or improved pain intensity, which was not clearly measured in this study. FBT was noted to be safe for long periods of time even with needed increase in its dose.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: Single-arm trial; quality of life not measured; limited duration of study

Nursing Implications

Pain management is an important aspect of improving a patient's quality of life. Nurses play a key role in assisting patients and providing pain management medications and in teaching patients how to manage their pain when they are outside an inpatient facility. Additional agents need to be available to assist in optimal pain control.

Print

Takeshima, N., Matoda, M., Abe, M., Hirashima, Y., Kai, K., Nasu, K., . . . Ito, K. (2014). Efficacy and safety of triple therapy with aprepitant, palonosetron, and dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy for gynecological cancer: KCOG-G1003 phase II trial. Supportive Care in Cancer, 22(11), 2891–2898. 

Study Purpose

To evaluate the efficacy of the triple therapy of aprepitant, palonosetron, and dexamethasone in patients with gynecological cancer receiving highly emetogenic chemotherapy

Intervention Characteristics/Basic Study Process

Women with gynecological cancer who were receiving highly emetogenic chemotherapy received 125 mg PO aprepitant before chemotherapy on day 1 and 80 mg on days 2 and 3, 0.75 mg of IV palonosetron before chemotherapy on day 1, and 9.9 mg of PO/IV dexamethasone before chemotherapy on day 1 and at 6.6 mg on days 2–4. The primary aim was to evaluate the number of patients with a complete response (CR) overall, which was defined as no vomiting and no use of rescue medication during the entire study period (0–120 hours postchemotherapy). The secondary aims were (1) to evaluate CR in the acute (0–24 hours postchemotherapy) and delayed (24–120 hours postchemotherapy) phases of treatment and (2) to evaluate complete protection (CP) defined as no vomiting, no rescue therapy, and no significant nausea overall and during the acute and delayed phases of treatment.

Sample Characteristics

  • N = 96  
  • MEDIAN AGE = 55 years (range = 32–75 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Gynecologic cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients receiving highly emetogenic chemotherapy that included cisplatin ≥ 50 mg/m².

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, multi-center study

Measurement Instruments/Methods

No information was provided on the measurement of nausea and vomiting. A Visual Analog Scale (VAS) may have been used, although this was not expressly stated and the range and timing of administration of the VAS was undefined.

Results

For the primary aim, overall CR rate was 54.2 %. For the secondary aim, evaluating the number of patients with CR in the acute and delayed phases of treatment, CR was 87.5% in the acute phase of treatment and 56.3% in the delayed phase of treatment. For the secondary aim evaluating CP overall and during the acute and delayed phases of treatment, CP overall was 44.8%, CP during the acute phase of treatment was 82.3%, and CP during the delayed phase of treatment was 45.8%.

Conclusions

The combination of aprepitant, palonosetron, and dexamethasone showed similar CR and CP rates when compared to existing two-drug combinations (e.g., a first-generation 5-HT3 receptor antagonist plus dexamethasone). These results would indicate that the triple therapy is a safe and effective method to manage chemotherapy-induced nausea and vomiting (CINV) in patients with gynecological malignancies receiving cisplatin-based chemotherapy.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Other limitations/explanation: No information was provided as to how the authors assessed nausea and vomiting, and as such we cannot know how valid or reliable the method of assessment was. The findings are only applicable to Japanese gynecological patients at this stage until further testing can take place in a more diverse sample.

Nursing Implications

CINV is often difficult to control and is especially prevalent in female patients. The combination of aprepitant, palonosetron, and dexamethasone has comparable rates of CR and CP when compared to other antiemetic regimens; however, the population used in this study has been shown to be at greater risk for severe CINV. This should be a recommended antiemetic regimen for gynecological patients receiving highly emetogenic chemotherapy.

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Takeda, Y., Kobayashi, K., Akivama, Y., Soma, T., Handa, S., Kudoh, S., & Kudo, K. (2001). Prevention of irinotecan (CPT-11)-induced diarrhea by oral alkalization combined with control of defecation in cancer patients. International Journal of Cancer, 92(2), 269–275.

Study Purpose

To evaluate the use of oral alkalization (OA) with control of defecation (CD)

Intervention Characteristics/Basic Study Process

  • Patients were given OA, consisting of 0.5 g NaHCO3 (sodium bicarbonate) and 0.5 g magnesium oxide, after meals and at bedtime with basic water (pH > 7.2) continuously for a total of 1,500-2,000 mL/d and 100 mg oral ursodeoxycholic acid 100 mg po 1–4 times daily after meals.
  • For CD (administering laxative treatment to avoid long contact time of irinotecan metabolite with bowel mucosa), patients were given up to 4 g per day of magnesium oxide and 2 L per day of excess basic water.
  • If patients experienced watery diarrhea with OA and CD, magnesium oxide was discontinued until symptom resolution.

Sample Characteristics

  • The study evaluated Japanese patients with small cell lung cancer or nonsmall cell lung cancer.
  • Group B consisted of 37 consecutive patients from three ongoing, prospective, phase I/II studies receiving irinotecan in combination with cisplatin in the presence of OA and CD.
  • Group A consisted of 32 control subjects without OA and CD who were matched to the background characteristics of the case patients treated with irinotecan and cisplatin.

Setting

The study was conducted at a single institution.

Study Design

This was a case-control study.

Measurement Instruments/Methods

  • Intraluminal pH, hematologic toxicity, and nonhemotologic toxicity were evaluated.
  • Gastrointestinal (GI) evaluation included recording appetite loss, nausea and vomiting, constipation, delayed diarrhea, and amount of loperamide used.
  • Dose intensity and response were recorded.
  • Use of loperamide was recorded. Patients received 2 mg loperamide on demand after every diarrheal episode. When this approach did not succeed, patients were managed with 2 mg of loperamide every 4 hours routinely until free of diarrhea for 12 hours.

Results

  • European Cooperative Oncology Group (ECOG) Common Toxicity Criteria (CTC) were measured.
  • The OA and CD group (group B) had the following results.
    • Higher stool pH (p < 0.0001)
    • Reduced incidence of delayed diarrhea at grade 2 or higher (group A = 32.3%, group B = 9.4%, p = 0.005)
    • Nausea (p = 0.0001)
    • Vomiting (p = 0.001)
    • Myelotoxicity (p = 0.03)
    • Lymphocytopenia (p = 0.034)
    • Dose intensification (from 34.6 to 39.9 mg/m2 per week [p < 0.001])
    • Tumor response rate of 59.3% versus 38.5% in group A (p = 0.173).
  • Duration of delayed diarrhea was 2.8 times longer in group A (p < 0.0001).
  • Loperamide use was greater in group A (p = 0.003).

Conclusions

Patient response rates did not indicate that OA and CD compromised the clinical efficacy of irinotecan and cisplatin therapy. Although a reduced amount of irinotecan and SN-38 may be circulated enterohepatically, the increased dose intensity conferred by OA and CD resulted in maintenance of the same degree of clinical efficacy.

Nursing Implications

OA and CD appeared to be useful in preventing the dose-limiting side effects of irinotecan, primarily nausea, vomiting, granulocytopenia, and delayed diarrhea.

Print

Takatori, E., Shoji, T., Miura, Y., Nagao, M., Takada, A., Nagasawa, T., . . . Sugiyama, T. (2015). A phase II clinical trial of palonosetron for the management of delayed vomiting in gynecological cancer patients receiving paclitaxel/carboplatin therapy. Molecular and Clinical Oncology, 3, 281–286. 

Study Purpose

To evaluate the efficacy of palonosetron plus dexamethasone in controlling delayed chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer receiving paclitaxel and carboplatin (a moderately emetogenic protocol)

Intervention Characteristics/Basic Study Process

On day 1 of therapy, palonosetron at 0.75 mg/body IV and dexamethasone at 19.8 mg/body IV were administered. On days 2 and 3, dexamethasone at 6.6 mg/body in 100 ml of normal saline IV was given. Patients were administered the Multinational Association of Supportive Care in Cancer Antiemesis Tool to complete on days 1–8. Only the first cycle of this protocol was evaluated. The patients rated the intensity of nausea using a Visual Analog Scale scored as mild (1–2), moderate (3–4), or severe (≥ 5).

Sample Characteristics

  • N = 42
  • MEDIAN AGE = 60.5 years (range = 32–83 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Gynecologic cancers including cervical, endometrial, and ovarian
  • OTHER KEY SAMPLE CHARACTERISTICS: Naïve to chemotherapy; aged ≥ 20 years; receiving a regimen of paclitaxel and carboplatin every three weeks; Eastern Cooperative Oncology Group performance status of 0–2; laboratory results related to bone marrow and hepatic and renal functions met criteria for chemotherapy infusion

Setting

  • SITE: Not stated 
  • SETTING TYPE: Not specified  
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care and palliative care

Study Design

Phase 2, nonrandomized, prospective, nonblinded clinical trial

Measurement Instruments/Methods

  • Self-completion of the Multinational Association of Supportive Care in Cancer (MASCC) antiemesis tool
  • Visual Analog Scale (VAS) to measure intensity of nausea
  • Complete response (CR) was defined as no vomiting, no additional antiemetic use, and no rescue therapy.  
  • Complete control (CC) was defined as complete control of vomiting with no antiemetic use, only mild nausea, and no rescue therapy.
  • Subgroup analyses were performed to comparatively assess the delayed CR rates by age (≥ 55 years versus < 55 years), body surface area (≥ 1.47 m2 versus < 1.47 m2), performance status (0 versus 1–2), and complications (present versus absent).

Results

The CR rate for the acute period (0–24 hours) was 95.2%, or 40 out of 42 patients. In the delayed period (24–96 hours), a CR of 90.5%, or 38 out of 42 patients, was reported. Overall, the CR rate was 85.7%, or 36 out of 42 patients. The CC rate for the acute period was 90.5%, or 38 out of 42 patients. For the delayed period, it was 85.7%, or 36 out of 42 patients. The CC rate was 78.6%, or 33 out of 42, overall. Nausea was reported in the acute, delayed, and overall periods by four, seven, and nine patients respectively. The average overall nausea score for the nine patients who reported nausea was 3.69+ 2.77 on a five-point VAS scale. Rescue antiemetics were used by two patients in the acute phase, four patients in the delayed phase, and in six patients overall. Granisetron and dexamethasone were the most commonly used rescue antiemetics. Adverse events were minimal with 16 patients experiencing constipation, three headache, and two diarrhea.

Conclusions

This trial supported the use of palonosetron over other 5HT3 receptor antagonists for the prevention of CINV in the 24–96-hour period following therapy in female patients with gynecologic malignancies. These data also support evidence that it is difficult to achieve CR for nausea as nine (20%) of the patients in this study experienced nausea.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding) 
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition) 

Nursing Implications

Palonosetron was especially helpful in the prevention of CINV during the delayed phase of moderately emetogenic chemotherapy. This study also measured nausea, which was helpful because many studies primarily address vomiting even though nausea often creates more patient distress.

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Takase, H., Sakata, T., Yamano, T., Sueta, T., Nomoto, S., & Nakagawa, T. (2011). Advantage of early induction of opioid to control pain induced by irradiation in head and neck cancer patients. Auris, Nasus, Larynx, 38(4), 495–500.

Study Purpose

To determine whether early induction of low-dose opioid for the treatment of mild pain improves dietary and caloric intake and reduces weight loss among patients with head and neck cancer

Intervention Characteristics/Basic Study Process

The low-dose opioid this study used was controlled-release oxycodone (CRO). The intial dose was 10 mg and the dose was titrated upward as needed. Because all patients agreed to use an opioid at some point, patients were classified into two groups, mild and moderate (referring to pain), according to when the opioid was introduced.

Sample Characteristics

  • The sample was composed of 43 patients, 23 in the mild-pain group and 20 in the moderate-pain group.
  • In the mild group, mean patient age was 63.6 years. In the moderate group, mean patient age was 63.7 years.
  • In the mild group, 2 patients were female and 21 patients were male. In the moderate group, 2 patients were female and 18 were male.
  • All patients had head and ceck cancers and were receiving radiation therapy from 40 Gy to a high of 60 Gy. (Not all patients received the highest dose.)

Setting

  • Single site
  • Inpatient
  • Department of Otorhinolaryngology, Fukuoka University Hospital, Fukuoka, Japan

Study Design

Prospective descriptive study

Measurement Instruments/Methods

  • Visual analog scale (VAS) (0 = no pain, 100 = unbearable pain), to measure pain
  • Caloric intake – caloric intake rate (Caloric intake rate was calculated by dividing the caloric intake by the basal energy expenditure [BEE]. Caloric intake was estimated from inpatient dietary forms and from what patients actually ate.)
  • Weight loss
  • Duration of time on a regular diet before the switch to a softer or liquid diet

Results

  • VAS pain scores were significantly lower in the mild group than in the moderate group, at 25–50 Gy.
  • The amount of oxycodone used for pain was significantly lower in the mild group than in the moderate group.
  • Patients in the mild group maintained a regular diet for a significantly longer period than did patients in the moderate group.
  • Caloric intake was significantly higher in the mild group, at more than 20 Gy.
  • Weight loss was significantly lower in the mild group, at more than 20 Gy.
  • The incidence of side effects was equal in both groups. Constipation and nausea were the most frequent side effects, followed by sleepiness, diarrhea, vomiting, itching, and dysuria.

Conclusions

Results indicated that the introduction of opioids for mild pain during radiotherapy controls the level of pain and increases the food intake of head and neck cancer patients. For such patients, use of opioids, beginning when pain is mild, may help to ensure a better dietary intake during radiotherapy.

Limitations

  • The study had a small sample, with fewer than 100 patients.
  • Researchers took almost four years to gather data.
  • The validity of the caloric-intake measures, based on what patients may have eaten, is questionable.

Nursing Implications

For the population of patients with head and neck cancer, maintaining food intake is a challenge, so this study is relevant. The intervention uses a standard pain control agent; the point at issue is the advisability of early intervention (early in terms of the World Health Organization ladder). The patient population pertinent to the study is very specific; the study is not generalizable.

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Takahashi, H., & Shimoyama, N. (2010). A prospective open-label trial of gabapentin as an adjuvant analgesic with opioids for Japanese patients with neuropathic cancer pain. International Journal of Clinical Oncology, 15, 46–51.

Study Purpose

To assess the usefulness of gabapentin in the treatment of cancer-related neuropathic pain

Intervention Characteristics/Basic Study Process

Patients who met the eligibility criteria of a score of 5 or greater on a numeric pain rating scale were entered. Gabapentin was begun at baseline at 200 mg and titrated to a maximum dose of 2,400 mg per day. Patients were asked to keep a pain diary and were assessed by a clinician throughout the 15-day study period.

Sample Characteristics

  • Twenty participants (10 men, 10 women) with a median age of 62 years (range of 31–74 years) were included in this study.
  • Participants had a variety of tumor types, with the most common being colon and lung cancers.
  • Of the total sample, 83% were inpatients, all were on opioids, 46% also were receiving nonsteroidal anti-inflammatory drugs, 79% were taking anticonvulsants, and 67% were on antidepressants.
  • The range of the opioid dose was 6–600 mg.
  • Fifty-four percent had pain from the tumor rather than from the treatment, and only 29% had actual peripheral neuropathy.

Setting

The study was conducted in a single-site inpatient setting in Japan.

Study Design

This was an open-label, prospective study.

Measurement Instruments/Methods

Measurements included a numeric pain rating scale using the Brief Pain Inventory, the McGill Pain Questionnaire, a numeric pain relief scale, and the Patient Global Impression of Change scale.

Results

A significant reduction was noted at various time points for worst, least, and average pain on the numeric scale (p < 0.004). Mean change in scores from baseline ranged from 0.6 to 1.3. No differences were found in any other outcome measure.

Conclusions

A statistical reduction in pain occurred as measured on the five-point numeric rating scale; however, the change was relatively small.

Limitations

  • The study had a small sample size, with less than 30 participants.
  • Neuropathic symptoms were found to be related to treatment in only 46% of patients in the study.
  • Pain was measured by various means, but no direct measures were specific to neuropathy.
  • No discussion took place as to whether there were any changes in analgesic regimens provided during the study.
  • No appropriate control or comparison groups were used.

Nursing Implications

The study findings do not provide strong support for the effectiveness of gabapentin for the management of cancer-related neuropathic pain or other symptoms.

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Takahashi, T., Hoshi, E., Takagi, M., Katsumata, N., Kawahara, M., & Eguchi, K. (2010). Multicenter, phase II, placebo-controlled, double-blind, randomized study of aprepitant in Japanese patients receiving high-dose cisplatin. Cancer Science, 101, 2455–2461.

Study Purpose

To evaluate the efficacy and safety of aprepitant plus standard therapy (granisetron and dexamethasone) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in Japanese patients with cancer undergoing treatment with chemotherapy including a highly emetogenic cisplatin-based regimen (≥ 70 mg/m2)

Intervention Characteristics/Basic Study Process

Patients were allocated to three groups.

  • The aprepitant 125/80 mg group received 125 mg on day 1 and a dose of 80 mg on days 2–5.
  • The aprepitant 40/25 mg group received of 40 mg on day 1 and a dose of 25 mg on days 2–5.
  • The standard therapy group received an oral administration of placebo on days 1–5.

All patients received standard therapy consisting of 40 µg/kg IV granisetron on day 1 and dexamethasone. Concomitant use of other antiemetics was prohibited from 48 hours before day 1 to the morning of day 6, except for rescue therapy for CINV.

Sample Characteristics

  • The study looked at 439 participants.
  • Mean age for the 125/80 group was 60.5 years (SD = 9.7 years); for the 40/25 group, 63.3 years (SD = 9.4); and for the standard group, 62.2 years (SD = 9.8).
  • Gender of patients was 24% female and 76% male.
  • Patient diagnoses were
    • 72% respiratory
    • 15% urogenital
    • 5% digestive
    • 5% eyes/ears/nose/throat
    • 3% other
  • Mean cisplatin dose (mg/m2) for the 125/80 group was 76.9; for the 40/25 group, 76.9; and for the standard group, 76.2.
  • Percentage of patients with a history of morning sickness was 42%; 8% of patients had a history of motion sickness.
  • Patients receiving cisplatin chemotherapy was 17%; chemotherapy except cisplatin, 21%, and CINV except cisplatin chemotherapy, 40%.

Setting

The study was conducted at multiple sites in Japan.

Phase of Care and Clinical Applications

Study participants were in active treatment.

Study Design

This was a phase II, placebo-controlled, double-blind, randomized parallel comparative study.

Measurement Instruments/Methods

  • Patients recorded in a symptom diary the onset of vomiting and nausea intensity on a 4-point scale, and the name and dose of any rescue therapy used along with the date and time from day 1 to the morning of day 6.
  • Safety was evaluated based on physical examination findings (vital signs, weight, general lab tests, lab values).
  • Toxicity was evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTAE).

Results

In the three study groups, the percentage of patients with complete response (no emesis and no rescue therapy) was 50.3% (standard therapy), 66.4% (aprepitant 40/25 mg), and 70.5% (aprepitant 125/80 mg). Efficacy was significantly higher in the aprepitant 40⁄25 mg and 125/80 mg groups than in the standard therapy group (p = 0.0053 and p = 0.0004, respectively), and efficacy was the highest is the aprepitant 125/80 mg group. The delayed phase efficacy was similar to the overall phase efficacy, indicating that aprepitant is effective in the delayed phase when standard therapy is not very effective. Aprepitant was generally well tolerated.

Conclusions

Aprepitant was shown to be more effective in the overall phase, including both acute and delayed, when compared to the standard group, irrespective of sex, age, or previous treatment with cisplatin.

Limitations

  • Limited information was provided regarding measurement tools.
  • The potential for anticipatory nausea was not addressed, especially in patients who had received previous emetogenic therapies.

Nursing Implications

Aprepitant used in combination with 5-HT3 receptor antagonists and a corticosteroid is effective in preventing CINV associated with highly emetogenic agents.

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Takahashi, T., Kumanomidou, S., Takami, S., Okada, T., Adachi, K., Jo, Y., . . . Suzumiya, J. (2016). A retrospective study of R-CHOP/CHOP therapy-induced nausea and vomiting in non-Hodgkin's lymphoma patients: A comparison of intravenous and oral 5-HT3 receptor antagonists. International Journal of Hematology, 104, 378–383. 

Study Purpose

To compare the effectiveness of oral versus IV 5-HT3s for chemotherapy-induced nausea and vomiting (CINV) prophylaxis in patients receiving R-CHOP or CHOP chemotherapy

Intervention Characteristics/Basic Study Process

Data were obtained from medical records of patients who received CHOP or R-CHOP as initial chemotherapy from 2006–2012. Symptoms for five days from the start of treatment were investigated. Risk factors influencing CINV were also investigated. CINV prophylaxis was an 5-HT3 alone.

Sample Characteristics

  • N = 72   
  • MEAN AGE = 68 years (SD = 12.1)
  • MALES: 45.33%, FEMALES: 44.66%
  • KEY DISEASE CHARACTERISTICS: Non-Hodgkin lymphoma

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Retrospective cohort comparison

Measurement Instruments/Methods

Complete response (CR) defined as no vomiting and no use of rescue medication.

Results

CR was observed in 80.6% of patients. No significant differences were observed in the CR rate between those who were given oral or IV antiemetics. Female gender and an age younger than 70 years were independent predictors of CINV.

Conclusions

IV and oral 5-HT3 had similar efficacy for CINV prevention; however, 5-HT3 alone may not be sufficient for prophylaxis for individuals with greater risk.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)

 

Nursing Implications

Oral and IV 5-HT3 achieved similar results for CINV prophylaxis. Female gender and younger age were independent risk factors for CINV.

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