To evaluate the effectiveness of the combination of palonosetron, aprepitant, and dexamethasone for prevention of chemotherapy-induced nausea and vomiting (CINV)

In cycle 1 of chemotherapy, safety and efficacy was assessed. In subsequent cycles, assessment of nausea was emphasized. Actual dosage and schedule of medications was not described. Patients completed Functional Living Index-Emesis (FLIE) scores at various time points in the study; however, these specific time points were not stated.

• The study consisted of 50 participants.
• Median age was 60.6 years, with a range of 31–68.9 years
• All patients were female.
• Diagnoses were ovarian, peritoneal, uterine, or fallopian tube cancer.
• The majority of patients (96%) had undergone previous surgery, but only one patient had received prior chemotherapy.
• All patients were scheduled to receive paclitaxel and carboplatin for several cycles.

All patients were in active treatment.

This was a prospective, open-label trial.

• Complete response (CR) was defined as no emesis and no need for rescue medications.
• The FLIE questionnaire was used.

• Four patients dropped out after experiencing uncontrolled nausea and vomiting.
• FLIE scores were reported for nausea and vomiting per cycles and days.
• The percent of patients experiencing CR was not reported.
• Treatment-related adverse events were few and of low grades.

The combination of drugs used appeared to be well tolerated. Firm conclusions regarding efficacy cannot be drawn.

• The study had a small sample.
• The study report did not provide much actual information or report overall results.
• Only cumulative drug dosages were reported; no information was provided about dosages and schedules.
• No control or comparison group was included.

This study provides some evidence that combinations of palonosetron, aprepitant, and dexamethasone can be well tolerated.

The purpose of the study was to establish the maximum-tolerated dose of paclitaxel and investigate whether prophylactic G-CSF and antibiotics would allow further dose escalation of paclitaxel in treatment-naïve patients.

Doses were given in increasing increments to groups of three patients to determine dose-limiting toxicity (DLT). Part A: Paclitaxel escalation without prophylactic G-CSF (unless DLT from neuropathy). Part B: Level 7 etoposide administered with G-CSF. Part C: Same as part B plus prophylactic antibiotics (ciprofloxacin and roxithromycin). With a hematologic toxicity recovery to CTC less than 3, a subsequent cycle was allowable with a max delay of two weeks. Dose reduction was given if grade 2 CTC hematologic toxicity persisted after a two-week delay and/or there was a greater than grade 2 nephro- or neurotoxicity.

• 47 participants were included in the study.
• Age range was 32–74 years.
• 31.9% were women; 68.1% were men
• Non-small cell lung cancer: squamous cell carcinoma (n = 20), adenocarcinoma (n = 18), other (n = 9)
• World Health Organization performance status 0 (n = 13), 1 (n = 29), 2 (n = 3), unknown (n = 2)
• Stage IIIA (n = 13), IIIB (n = 9), and IV (n = 25).

Single-site outpatient setting in the Netherlands.

Active treatment

Prospective dose-finding study.

• Dose-limiting toxicity: defined as granulocytes less than 0.5×10⁹/L lasting for seven days or more, granulocytes less than 0.5×10⁹/L, fever of 38.5ºC or higher, platelet count less than 25×10⁹/L, and any toxicity higher than grade 2 (with the exception of nausea/vomiting responsive to treatment) occurring during the first cycle
• Blood cell counts: WBC, ANC, platelets, hemoglobin
• Adverse events: fever, polyneuropathy, anorexia, nausea, vomiting, diarrhea, cardiac, asthenia, hemorrhage, electrolyte disorder, hematologic toxicity
• Infections
   

In total, 189 cycles of chemotherapy were administered. Forty-three of the 47 patients enrolled survived treatments. Thirty-four completed the full protocol (febrile neutropenia or dose delays from toxicity were the main reasons for incomplete cycles).

The use of G-CSF and antibiotics allows for higher chemotherapy doses in patients with stage IIIA, IIIB, and IV non-small cell lung cancer, which could increases survival.

• Small sample (less than 100 participants)
• The findings circumvent details about survival time in the patients who received G-CSF and prophylactic antibiotics allowing for higher chemotherapy doses; therefore, it is unknown if the patients who survived the longest were the recipients of the higher chemotherapy doses with G-CSF and antibiotics, which was the goal of the study.
   

The administration of G-CSF and prophylactic antibiotics may reduce neutropenia and infections increasing the DLT, allowing for higher doses of chemotherapy for better chance of prolonged survival. However, research in this area needs further exploration.

To evaluate the efficacy of probiotics in the prevention of radiation-induced diarrhea

Patients who had undergone adjuvant, postoperative radiation to the abdominal or pelvic area, alone or in combination with chemotherapy, and were admitted to the hospital were randomized to one of two groups: “5” Strain Dophilus (L group) or Hylak Tropfen Forte drops (H group).

• The study reported on 42 patients.
• The median age of patients in the L group was 62 years with a range of 34–82 years, and the median age of patients in the H group was 67 years with a range of 43–83 years.     
• The sample was 66% male and 33% female.
• The majority of patients in the L group had colorectal cancer and the majority of patients in the H group had prostate or rectosigmoid junction cancer.
• The number of patients in the L group with a body mass index (BMI) of normal weight was equal to the number of patients with an overweight BMI. In the H group, more patients had an overweight BMI than a normal BMI.
• In the L group, 55% of patients also received chemotherapy. In the H group, 50% of patients also received chemotherapy.
   

This study was conducted at a single-site, inpatient setting in Ruzomberok, Slovakia.

All patients were undergoing the active treatment phase of care.

This was a randomized, parallel-group, nonplacebo controlled trial.

Patient diaries were used to record the number and consistency of stools, presence of bleeding or abdominal pain, and use of antidiarrheals or antibiotics.

• Patients in the L group had a higher number of daily bowel movements (BMs) (n = 4.16, range = 1.2–9.7) than in the H group (n = 2.52, range = 0.7–5.3).
• In the second week, the weekly number of BMs was significantly higher in the L group (p < 0.01) compared to the H group.
• The number of BMs in the H group increased at week 3.
• A significant increase was reported in the number of BMs in patients receiving only radiation versus radiation plus chemotherapy.
• Fewer patients in the L group (27%) required an antidiarrheal (specifically diphenoxylate) compared to the H group (55%).
• Fewer patients in the L group (9%) required antibiotics versus in the H group (25%).
• Abdominal pain was similar between groups with 25% of patients reporting the side effect in the L group compared to 22% in the H group.
• One subject in the H group reported blood in the stool at day 9.

Probiotics  may be effective in the prevention of radiation-induced diarrhea.

• The sample size was small, with fewer than 100 patients.
• A control group was not included.
• Patients' diets and the radiation technique could have varied between groups.

The use of probiotics may have some benefit in the prevention of radiation-induced diarrhea; however, more studies (including control arms) are needed.

Identify whether aqua lymphatic therapy (ALT) is a safe method of treatment for lymphedema

ALT, which uses the physical properties of water to enable women to perform self-massage and exercises, was performed weekly in the intervention group during 45-minute sessions in a warm (32–33º C) hydrotherapy pool 1.2 m deep. The control group was instructed to continue to perform the self-management measures as usual up to the beginning of the study.

• The study sample was comprised of 48 female patients.
• Mean age was 56 years, with a range of 31–81 years.
• All patients had unilateral lymphedema secondary to breast cancer surgery with axillary node dissection.
• Patients had undergone or completed Intensive complex physical therapy and were at least two weeks in the self-management state.

The study took place in an outpatient setting hydrotherapy pool in Ramet Ga, Israel.

The study used a single-blinded randomized controlled trial design.

• Volume of limbs was measured using water displacement.
• Adherence to treatment was assessed using an adherence diary.
• Quality of life, including physical, psychological, and social withdrawal factors, was assessed using the Upper Limb Lymphedema Questionnaire (ULL 27).
• Safety was determined based on an absence of related infections.

No infections or worsening of limb volume was noted in the post-treatment evaluation. Mean adherence to self-management was 28%. Adherence in the ALT group was 79%, possibly because of the low frequency of therapy and group exercise. The warm temperature environment of the water has an immediate positive influence on limb volume, but no long-term effect was observed. The ALT group showed improved emotional and social dimensions, while the control group demonstrated a worsening quality of life, despite unchanged physical dimensions.

ALT was found to be a safe method for maintenance therapy in patients with mild-to-moderate arm lymphedema. Warm water temperature environment appeared to have an immediate short-term positive influence on limb volume.

• The study sample was small, with less than 100 patients.
• Randomization did not produce two similar groups in all baseline measures, such as breast and chest wall radiation, chemotherapy, and type of surgery; however, these measures were not found to be a factor in the study.

Access to warm water public pools and cleanliness of pools is essential to avoid ear, sinus, and respiratory infections. Staph bacteria, the usual cause of skin infections, is not described in the literature as being present in pool water. Patients should be cautioned to not participate in ALT if they have skin infections, cuts, or wounds. The quality of life improved in the ALT group, while it declined in the control group, despite no physical changes in limb volume between the two groups. This might indicate that offering something, or a different, exercise could positively impact quality of life and potentially adherence.

• FINAL NUMBER STUDIES INCLUDED = 26
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,830
• SAMPLE RANGE ACROSS STUDIES: 10 of 26 had a sample size less than 30
• KEY SAMPLE CHARACTERISTICS: 13 studies of breast, 3 of prostate, 2 of colorectal, 2 of nasopharyngeal, 2 of hematological, 1 of gynecologic, and 3 of various types of cancer. The mean age ranged from 40–70.6 years. Twelve studies reported cancer stage from mostly I to III. Eight studies included patients who had completed active treatment.

PHASE OF CARE: Active antitumor treatment

Exercise was supervised or home-based, 15–50 minutes in length, two to five times per week for 6–24 weeks. Overall aerobic exercise had a small but significant effect (p = 0.01). Studies with patients past active treatment had a moderate effect on fatigue compared to usual care (p < 0.01). Professionally led exercise led to significant improvements in fatigue (p = 0.02). Professionally led exercises lasted 20–30 (p < 0.01) or 50 minutes (p < 0.02), two to three (p < 0.01, p = 0.01) times per week for eight weeks (p < 0.01). No significant difference by exercise type existed.

Structured exercise can have a positive effect on CRF. The effect may be greater when activity is professionally led and after active treatment.

• The majority of patients had breast cancer, limiting generalizability.
• Other potential contributing factors to CRF were not reported in these studies.

Consistent physical activity should be discussed with patients with cancer to lessen the effects of CRF.

To compare single-dose palonosetron with single-dose granisetron in the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) with cisplatin for moderately emetogenic chemotherapy

Subjects were stratified according to having chemotherapy with cisplatin and were randomly assigned to either palonosetron during cycle 1 and granisetron during cycle 2 or the opposite sequence of antiemetics. Patients receive 0.25 mg IV palonosetron or 3 mg IV granisetron 30 minutes prior to chemotherapy infusion. Other drugs with antiemetic efficacy, including dexamethasone, were not permitted; however, use of rescue medication was allowed. Use of rescue medications was standardized. Patients used diaries to record the number of emetic episodes.

• The study consisted of 122 participants.
• Patients' mean age was 52.2 years (SD = 10.67 years), with a range 17.36—74.78.
• The sample was 46.6% female and 53.4% male.
• Cancer types were lung, breast, colorectal, and gastric.
• Approximately 40% of participants had received previous chemotherapy and experienced prior CINV.
• All patients were scheduled to receive two courses of moderately emetogenic chemotherapy (MEC) or cisplatin 60–80 mg/m².
• Patients were excluded if they were scheduled to receive highly emetogenic chemotherapy or radiotherapy to the upper abdomen or cranium.
• Patients were excluded if they had grade 2 or 3 CINV within 24 hours prior to the start of the study.
• All patients had a life expectancy of three months or more.

The study was conducted at multiple sites in China.

All patients were in active treatment.

This was a randomized, double-blind, crossover comparative trial.

• Patients recorded the number of emetic episodes, maximum severity of nausea, onset of initial symptoms, and use of rescue antiemetics in diaries.
• Nausea was graded on 4-point Likert-type scale according to degree of interference with normal daily life.
• Complete protection(CP) was defined as no emetic episodes and no use of rescue medication. Major protection was defined as 1–2 emetic episodes. Treatment failure was defined as three or more episodes of vomiting.

• No significant differences were found between treatment groups during the acute, delayed, and overall phases.
• Palonosetron and granisetron were comparable in terms of complete response rates (72.16 with palonosetron and 67.74 with granisetron).
• Time to onset of the first emetic episode was similar in both groups.
• Both drugs were well tolerated, and no serious adverse events were reported.
• Constipation and dizziness were the most frequently observed adverse events in both groups.

The efficacy of single-dose, 0.25-mg palonosetron was not inferior to 3 mg granisetron for the prevention of CINV in the acute, delayed, and overall periods.

• Adherence to diary recording was not discussed.
• Use of rescue medications was not discussed.
• This study compared only two drugs with single-dose administration, which are not recommended for standard antiemetic approaches.
• Nausea was defined in terms of interference with life activities rather than the experience of the symptom.

Palonosetron appears to have similar efficacy as granisetron for prevention of CINV in patients receiving MEC.

To determine the efficacy and safety of radiofrequency ablation with percutaneous osteoplasty in the treatment of painful extraspinal bone metastases resistant to the conventional treatment of pain

Radiofrequency ablation involved the insertion of a needle at the bone lesion using a local anesthetic. An electrode was inserted into the needle and delivered heat from 70–90°C for a mean duration of 8.6 minutes. Immediately after this procedure, bone cement was injected into the lesion through the needle. The procedure was guided by fluoroscopy, and the amount of bone cement was determined by measuring the tumor size (the mean volume of bone cement was 6.6 ml; SD = 4.6 ml). The patient underwent a computed tomography scan after the injection of bone cement. Study measurements took place at baseline, 24 hours after treatment, and at the three- and six-month follow-up.

• N = 38  
• MEAN AGE = 52.6 years (SD = 12.2 years)
• MALES: 53%, FEMALES: 47%
• KEY DISEASE CHARACTERISTICS: Most frequent diagnosis was lung cancer followed by breast, thyroid, and liver cancers with a life expectancy of less than three months; number of treated lesions ranged from one to three

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Shanghai, China

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care 

Retrospective, single-arm, repeated-measures study; patients served as their own controls

Pain was measured by a 0–10 Visual Analog Scale (VAS), and quality of life was assessed using the Karnofsky Performance Status (KPS) scale. Data were collected by one physician at baseline and 24 hours after the intervention. Follow-up measurements (three and six months) were made at the outpatient office visit or by a telephone interview. Pain medication used by the patient was also documented. Functional recovery was evaluated by the patient’s ability to walk, and technical success was determined by the absence of major complications as defined by the Society of Interventional Radiology.

There was significant pain reduction (p < 0.001) compared to baseline as measured by the VAS at baseline, 24 hours, three months, and six months. Also at these time points, quality of life significantly improved (p < 0.05) as measured by the Karnofsky performance scale. Six months later, 32 patients no longer used narcotic analgesia (eight of these patients now used NSAIDs). Ten of the 25 patients who had limited walking ability before treatment were able to walk immediately after treatment. Six months later, 16 of the 25 patients’ ability to walk increased and walking became normal for five patients. Walking ability was worse for two patients. One patient experienced a vasovagal reaction during the procedure which may have been related to the lesion location. Minor complication rate was 23.7% and included 8 episodes of a small cement leakage into the soft tissue (resolved within 24 hours) and one episode of first-degree skin burns.

Radiofrequency ablation with percutaneous osteoplasty is a new treatment that shows promise for treating painful bone metastases. Although this study demonstrates its safety, efficacy, and feasibility, further study is needed with a larger number of patients.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Findings not generalizable
• Other limitations/explanation: All patients were from one medical center.

Radiofrequency ablation with percutaneous osteoplasty is a palliative care intervention that nurses should be aware of as they may be caring for patients who receive this treatment once additional scientific evidence is established. Nurses should be knowledgeable of potential complications that may result from the procedure (i.e., skin burns, cement leakage).

To explore the responses, in terms of self-image and psychiatric symptoms, of women with breast cancer to an art therapy intervention

The art therapy intervention consisted of five sessions in which participants were encouraged to express feelings and thoughts. Participants’ pictures were used as a mode of expression, followed by reflective dialog. Two experienced art therapists conducted interventions and patient interviews, so that the therapist did not function as both interviewer and therapist for the same patient. Art therapy sessions were provided during adjuvant radiation therapy. Study data were collected at baseline, after two months, and after four months.

• The study reported on a sample of 41 patients.
• Median patient age was 59 years, with a range of 37–69 years.
• All the patients had breast cancer (100% female sample) and had received adjuvant radiation therapy. No other specific diagnostic information was provided.
• No demographic data were reported (other than age). A few patients in both groups were receiving antidepressants. About 50% of patients had received chemotherapy prior to radiation therapy, and 41% had received hormone therapy.

• Single site
• Outpatient setting
• Sweden

• Phase of care: active treatment
• Clinical applications: late effects and survivorship

Randomized controlled trial with longitudinal analysis

• Structural analysis of social behavior
• Symptom Checklist-90 (provides symptom-subscale scores and measures of general severity)
• Interview

At baseline, all participants had similar self-image scores and scores for depression, anxiety, and general symptom severity as a group of females undergoing radiation therapy for breast cancer who are otherwise healthy. Those who received art therapy showed a decrease in symptoms of anxiety and depression (p < 0.01). Control patients’ symptom levels remained essentially stable. Regression analysis showed that surgery, chemotherapy, parenthood, and study group were significant predictors of depression and anxiety as measured at the end of the study (p < 0.05). Axillary surgery and hormonal treatment predicted higher ratings of anxiety. Subjects’ positive and negative self-image scores were not different between study groups and did not differ significantly from healthy controls.

Participation in art therapy was related to lower patient ratings of depression, anxiety, and somatic symptoms. Axillary surgery and hormonal treatment were predictive of higher levels of anxiety and depression.

• The study had a small sample, with fewer than 100 participants.
• No attentional control was provided.
• It is unclear whether art therapy sessions were provided individually or in groups, a factor that could have affected results.
• There was an overall drop-out rate of 24% from the initial randomized sample.
• Baseline scores relating to depression and anxiety were actually lower in study patients than those of a healthy comparison group, leading one to question the clinical relevance of study findings overall.
• Measurement methods used in the study did not include those commonly used in other research.
• Authors reported minimal demographic informatio, a factor that may limit generalizability.

Findings suggest that art therapy might be helpful in management of symptoms of depression and anxiety in women with breast cancer; however, the clinical relevance of findings is unclear. Further well-designed research is needed to confirm these preliminary findings.

To assess the efficacy and 12-week tolerability of intranasal fentanyl spray (INFS) in patients with cancer-related breakthrough pain

Doses were titrated to achieve efficacy. Patients with doses titrated to 200–400 mcg were entered into an efficacy phase in which eight episodes of breakthrough pain were treated. Episodes were randomly treated with INFS or a placebo. Patients with doses titrated to 50 or 100 mcg were directly entered into a tolerability phase. Patients with titrated doses of 200 or 400 mcg entered a tolerability phase after the treatment of eight breakthrough episodes. Patients recorded pain, adverse effects, and impressions of efficacy daily in a diary. Pain was recorded at baseline and at two, 10, 30, and 60 minutes after taking INFS. Local nasal tolerability was assessed by an otorhinolaryngologist at baseline and at the end of the study.

• N = 46
• MEDIAN AGE = 61 years (range = 38–79 years)
• MALES: 32.6%, FEMALES: 67.4%
• KEY DISEASE CHARACTERISTICS: Most frequent tumor types were breast, urothelial, and gastrointestinal; 54% had bone metastases

• SITE: Multi-site  
• SETTING TYPE: Not specified  
• LOCATION: Several European countries

Double-blinded, placebo-controlled, crossover trial

• 11-point Numeric Rating Scale (NRS)  
• The difference between pain ratings at baseline and each time point for breakthrough episodes was calculated.
• Clinical nasal examination

Mean differences in pain were greater for INFS compared to a placebo at 10, 30, and 60 minutes (p < 0.02). In total, 61% of patients receiving 400 mcg responded at five minutes. The most common adverse nasal events were change in mucosa color, runny nose, inflammation, stuffed nose, and edema, which occurred in four to five cases. None were considered serious. Other events reported were dizziness, nausea, fatigue, and vomiting. Half of these were considered to be treatment-related. The adverse event profile was similar for all dose levels.

INFS was effective for the management of breakthrough pain compared to a placebo, and it was not associated with severe nasal side effects over a 12-week period. Other side effects seen were those typical of opioid treatment.

• Small sample (< 100)
• Measurement validity/reliability questionable
• Other limitations/explanation: Reliance on patient diaries for pain reporting at specific time points; adherence and missing data were not discussed

This study added to the body of evidence showing that INFS is effective in the management of breakthrough pain. The rapid, effective relief of breakthrough pain is an important goal for pain management. The examination of the nasal cavity in this study added to relevant information, showing its overall tolerability over a 12-week period. Ongoing research with longer periods of follow-up are needed.

STUDY PURPOSE: To summarize evidence and quantify the effects of reiki on pain and anxiety

• FINAL NUMBER STUDIES INCLUDED = 7
• TOTAL PATIENTS INCLUDED IN REVIEW = 328
• SAMPLE RANGE ACROSS STUDIES: 16–60 patients
• KEY SAMPLE CHARACTERISTICS: 48% women; mean age 63 years; three studies were in patients with cancer; two studies tested the intervention in a surgical setting; two studies used reiki in community-dwelling adults

The effects sized for within-group differences ranged from d = 0.24 for decreased anxiety in women undergoing breast biopsy to d = 2.08 for decreased pain in community-dwelling adults. For reiki versus a rest intervention in patients with cancer, the effect for a decrease in pain was d = 0.032, and the effect in community-dwelling adults was d = 0.45. A detailed discussion of individual studies showed some mixed findings, particularly for one study in which reiki was compared to both sham reiki and usual-care groups. The median number of study participants was 24. It was noted that it took more than a year to recruit a small number of subjects in some trials. The timing, number of sessions, and specific applications of reiki varied.

Data were insufficient to draw any generalizations regarding the effects of reiki on anxiety or pain. The magnitude of the effect sizes calculated suggests Reiki may be helpful, but more rigorous trials with larger samples are needed to fully evaluate its efficacy.

• Limited number of studies with only three in patients with cancer
• Sample sizes were small
• No quality evaluation of studies was include
• Timing and length of the intervention varied substantially, and most were for very short durations with few reiki sessions

This review did not demonstrate clear efficacy of reiki for pain or anxiety. However, the effect sizes shown here suggest that additional, wel- designed research is warranted. The authors made a note of the difficulty in recruiting patients to these trials and high attrition rates, particularly in the control groups. They suggested that the of a crossover design would be helpful to address these problems. The timing and length of treatment needs to be considered based on the desired effects and context of the patient situation. As much as possible, the standardization of the reiki intervention and the use of a sham control would be helpful to evaluate potential placebo effects.