Zinc – 25 mg  versus placebo, 3x/day for 2 months

Patients started capsules on first day of RT and continued until completion of RT.

Block randomization

The study was comprised of 100 patients, 50 zinc, 50 placebo, with a mean age of 50–51 years.

RT dose 180–200 cGy daily in five weekly fractions

41-42% patients receiving RT + chemo
 

Jan 2003 – Aug 2004

Double-blind, randomized, placebo-controlled study

RTOG acute morbidity scoring

Serum zinc levels were higher in the zinc group: 20.5 versus –1.5 (p = 0.02).

Grade 2 mucositis appeared earlier in the placebo group (p = 0.017 and larger proportion of patients).

Grade 3 mucositis also earlier and larger proportion of patients, p = 0.0003.

Results not as significant for patients receiving concurrent chemo.
 

Oral analgesics prescribed for pain.
 

Recommend continuing treatment out past end of RT as patients in both groups had similar recoveries.

Need to determine optimal dose.

To identify patients in high-anxiety states and to test the effects of a music intervention

Cancer and its treatment provoke a series of changes in the emotional sphere of patient anxiety. In addition, there is a subgroup of patients who are in a high-anxiety state. These patients, when identified, obtain the most benefits from music or verbal relaxation. This study consisted of 98 patients in three groups: the music therapy group, which received 60-minute, single-music sessions; the verbal relaxation group, which received 30 minutes of guided relaxation; and the control group, which received usual care. Because patients were asked to rate their anxiety preintervention, the study also was able to test the intervention's effects on those in high-anxiety states.

• N = 98
• AVERAGE AGE = 53 years
• MALES: 34%, FEMALES: 66%
• KEY DISEASE CHARACTERISTICS: Primarily patients' first chemotherapy session
• OTHER KEY SAMPLE CHARACTERISTICS: Participants who were married were more prevalent. Breast cancer was more prevalent than lung or other cancers. Cancers were in stages 2 and 3. Elementary-level education was the most prevalent educational status.  

• SITE: Single-site  
• SETTING TYPE: Outpatient  
• LOCATION: Outpatient clinic, University Medical Center, Taiwan

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics, elder care, palliative care 

Randomized, controlled trial

• Spielberger State-Trait Anxiety Instrument (STAI)
• Emotional Visual Analog Scale (VAS)  
• Three biobehavioral indicators, skin temperature, heart rate, and consciousness level, were measured before and after chemotherapy.

All groups experienced a significant decline in anxiety. The music intervention group experienced a greater decrease in poststate anxiety (p = .005). Physiologic indicators also changed in patients with high-anxiety states in the music therapy group. This study highlighted the need to target patients in high-anxiety states and to offer additional support, relaxation, and interventions such as music therapy to this population.

Music intervention and relaxation therapy reduces chemotherapy-induced anxiety.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Selective outcomes reporting
• Key sample group differences that could influence results
• Other limitations: This study is difficult to reproduce as it requires one-on-one staff time. Relaxation and music during chemotherapy often is interrupted. Baseline anxiety was lower in the music intervention group.

This study highlighted the need to identify patients in high-anxiety states pretreatment. This population can then be offered additional interventions. Music and relaxation can reduce anxiety during chemotherapy. Most infusion centers offer personal music devices or allow patients to bring their own. Music can be offered via headphones if a patient desires. This intervention can be recommended safely.

To study the effect of step-therapy policy requiring an older 5-HT₃ receptor antagonist (RA) prior to palonosetron on the risk of chemotherapy-induced nausea and vomiting (CINV) associated with hospital or emergency department (ED) admissions

Patients with a diagnosis of breast or lung cancer and receiving moderately emetogenic chemotherapy (MEC) (cyclophosphamide, carboplatin) or highly emetogenic chemotherapy (HEC) (cisplatin) were selected from the PharmMetrics claims dataset (providing drug name, quantity dispensed, and length of supply) between January 2005 and June 2008. CINV events were followed for six months from initial chemotherapy administration through ICD-9-CM codes. Study duration was six months from the index chemotherapy date, and antiemetics investigated included dolasetron, granisetron, ondansetron, and palonosetron. Patients were divided into two groups: those initiated with palonosetron and maintained on the drug for the duration of the study and those who began therapy with one of the older 5-HT₃ RAs and maintained on the initial drug or alternated between any 5-HT₃ RAs. The use of dexamethasone was assessed for both groups. CINV events were calculated using paid and filed claims with ICD-9 codes for nausea, vomiting, or dehydration, and those with hospital admissions were selected.

• This study reported on 9,257 patients.
• Ages ranged from 53.7–65.03 years.
• The sample was 33.6% male and 66.4% female.
• Patients had been diagnosed with breast or lung cancer.
• Patients were chosen based on having at least six months of records available prior to the study index date; no prior history of vomiting, nausea, or dehydration during the six months preceding the index chemotherapy; and a follow-up period of at least six months after the first date of the first chemotherapy treatment cycle.

The study was conducted in multiple settings in the United States. Specific sites were not reported.

All patients were in active antitumor treatment.

This was a longitudinal, retrospective cohort study.

• Severity of patient conditions identified through comorbidities were summarized using an aggregate measure, the Charlson Comorbidity Index (CCI).
• CINV events associated with hospital/ED admissions were selected.
• Investigators calculated treatment days with CINV events.

Patients with breast or lung cancer receiving MEC who were initiated and maintained on palonosetron were at significantly lower risk for potentially costly CINV versus those on older 5-HT₃ RAs. More studies indicating the impact of step-therapy policy are necessary.

• A risk of bias exists because of the sample characteristics.
• The authors used selective outcomes reporting.
• Findings may not be generalizable to other populations.
• CINV events were based on pharmacy claims and not actual CINV experiences.
• The majority of these patients had health insurance and, thus, could take palonosetron, which is more expensive. People of low economic status may be unable to obtain coverage for this expensive drug.
• Additional important variables that could affect patients’ CINV experiences are not found in claims data. These include race, alcohol consumption, cancer staging, and history of motion sickness. The claims dataset used in this study was mainly employer-based. Because the sample had one cohort of breast cancer, more than two-thirds of patients were female, and female patients experience more CINV than males.

Patients with breast or lung cancer undergoing MEC or HEC who are initiated and maintained on palonosetron experience fewer CINV events compared to patients receiving older 5-HT₃ RAs. Nurses should be aware that palonosetron is more expensive than older 5-HT₃ RAs, and, thus, patients with low economic status or who are self-insured may not be able to pay for this drug. The reduced antiemetic claims noted here suggest that cost may be equivalent because palonosetron requires fewer doses.

To assess the effectiveness of inhaled ginger essential oil in reducing the incidence of chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer as a complementary intervention to standard antiemetic care, and to assess the patients’ quality of life (QOL) related to their health following aromatherapy

An aromatherapy necklace was worn by the participants for five days, 24 hours/day, after receiving highly emetogenic chemotherapy. It was used for patients to inhale at least three times a day. Patients were assigned to two groups: For course 1, Group 1 had a ginger fragrance oil (placebo) in the necklace while Group 2 had ginger essential oil. For course 2, Group 1 had the ginger essential oil while Group 2 used the fragrance oil. Standard antiemetics were also given prior to chemotherapy—IV granisetron and IV dexamethasone in addition to scheduled take-home medications of oral granisetron, oral dexamethasone, and oral metoclopramide. Data were collected at baseline, on days 1–5, and on day 8.

• N = 600   
• AGE RANGE = 20–79 years
• MEAN AGE = 47 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Received an anthracycline and cyclophosphamide

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

• PHASE OF CARE: Active antitumor treatment

• Single-blind, randomized, controlled, cross-over study

• 100 mm visual analog scale (VAS) in a diary card
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

The use of ginger essential oil inhalation significantly lowered the VAS nausea score during the acute phase (p = 0.04) compared to the placebo, but its effect was not sustained over time. No appreciable effect on vomiting was revealed. Inhaled ginger essential oil positively affected the global health status from baseline.

Inhaled ginger essential oil did not demonstrate significant reductions in CINV and may not be effective as complementary therapy for CINV overall. It may be a useful adjunct for nausea symptoms.

• Baseline sample/group differences of import

No evidence suggested that the use of inhaled ginger essential oil is effective in improving CINV control, but it may be helpful in improving QOL during treatment. Further research is warranted as nausea control continues to be a challenge.

To compare the efficacy of dioctahedral smectite and iodine glycerin (DSIG) cream to a topical mouth rinse in the treatment of chemotherapy-induced oral mucositis

After oral mucositis (OM) developed, patients were randomized to receive DSIG or a topical rinse solution administered by two nurses. Nurses were not blinded to the intervention. The DSIG cream consisted of 3 g of dioctahedral smectite and 10 ml of iodine glycerin. The cream was applied to oral mucosa four times per day for one hour during each application while the patient was fasting. The topical mouth solution consisted of saline 400 ml, gentamicin 640,000 u, and vitamin B12 500 mg. Patients rinsed with the solution four times per day and gargled the solution for one minute with each application. Both treatments were administered for five consecutive days. Data were collected daily once OM was identified and continued for five days.

• N = 130  
• AVERAGE AGE = < 53 years (46.9%), ≥ 53 years (53.1%)
• MALES: 72.3%, FEMALES: 27.7%
• KEY DISEASE CHARACTERISTICS: Multiple types of cancer

• SITE: Single-site    
• SETTING TYPE: Not specified    
• LOCATION: China

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• Oral Assessment Guide (OAG)

Both groups of patients had OM of similar severity on day 1 of the study. Over the five days of the study, when compared to a topical rinse solution, DSIG improved the severity of OM. Patients who received DSIG healed faster than those who received the topical rinse. DSIG is a promising treatment for chemotherapy-induced OM, and additional studies to compare DSIG to other available OM treatments and to study the efficacy of DSIG over a longer period of time are needed. Studies also are needed to determine whether DSIG has a role in the prevention of chemotherapy-induced OM.

• Risk of bias (no blinding)

DSIG may be a useful intervention for patients who already developed chemotherapy-induced OM. Patients who received the DSIG treatment had less severe OM than those who received a topical rinse solution, and they had a faster rate of healing and more thorough healing. Nurses can conduct physical assessments of patients to determine the extent to which OM is present and educate patients about the various options for OM treatment.

To examine the differences between caregiver quality of life when caring for a patient in a home hospice program and an ambulatory patient receiving formal palliative care program services

Governmentally supported home hospice services provided to patients with advanced cancer by a multidisciplinary team

• N = 258   
• MEDIAN AGE = 41–50 years
• MALES: 33%, FEMALES: 67%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Patients with advanced (stage III/IV) mixed cancer diagnoses and expected to live at least three months 
• OTHER KEY SAMPLE CHARACTERISTICS: Caregivers had to be aged at least 21 years and able to communicate in either Mandarin or English 

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Singapore

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

Cross-sectional study with combined data from two studies

• Caregiver Quality of Life Index-Cancer (CQOLC)
• Domain-specific and validated in both ambulatory and hospice care settings

Significant Pearson intercorrelations (rs = 0.18-0.84, ps < 0.05) for CQOLC total scores and subscales excluding positive adaptation and disruptiveness subscales were found. Males had significantly lower total CQOLC scores (p = 0.012) and disruptiveness scores (p = 0.003). Significantly lower CQOLC scores also resulted in caregivers caring for parents (and tertiary education [all values = p < 0.05]). Chinese ethnic caregivers had better QOL related to burden (p = 0.031) and financial concerns (p = 0.024), but less successful positive adaptation resulted in lower QOL (p = 0.024). Although data analysis controlled for significant differences in age and spousal caregiving, ambulatory patient caregivers were older and more likely to be spousal caregivers. Analysis of covariance (ANCOVA) supported home hospice caregivers experiencing better QOL than ambulatory patient caregivers but only in total CQOLC scores (p = 0.008) and subscales of financial worries and burden (p = 0.004).

Home hospice care programs for patients with palliative cancer care needs appear to benefit caregiver QOL, particularly in minimizing perceptions of burden and financial concerns. Those programs, composed of multidisciplinary teams focused on responding to patient end-of-life needs, seem to improve caregiver confidence in care and satisfy caregivers’ desire for personalized support by healthcare providers.

• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Lack of control on potential study confounding variables; study focus on Chinese caregivers only, so data findings cannot be generalizable.

Models of home hospice services to mutually benefit caregivers and those they care for need further testing in a variety of cultures with variant healthcare systems to more clearly validate the efficiency of and benefits of those models in meeting caregiver improved QOL.

To document changes in symptoms after acupuncture or nurse-led supportive care in patients with incurable cancer and to determine the feasibility of carrying out a randomized trial in acupuncture for patients with advanced incurable cancer

Patients were randomly assigned to either an acupuncture group or a nurse-led supportive care group. In the acupuncture group, traditional Chinese medical acupuncture was performed by the principle investigator, a radiation oncologist, and a certified medical acupuncturist. The acupuncture points were chosen based on the symptoms experienced. The acupuncture needles were connected to an electric stimulator, and a 0.3 ms duration, 4 Hz alternating current was delivered. The needles were stimulated for 20 minutes and then removed.

In the nurse-led supportive care group, patients met for 20–30 minutes with an experienced palliative care nurse weekly for four weeks, comparable to the time spent in acupuncture. The nurse explored their most troubling symptoms and discussed medications and nonpharmacologic therapies such as relaxation therapy, professional counseling, exercise, or judicious rest. The patient’s interpretation of the causes of the symptoms and how they could be ameliorated were discussed. The nurse also addressed issues such as improving the scheduling and dosing of the medications and alternative therapies to drugs, such as foods for managing constipation. Useful strategies for coping with daily activities and emotional support were discussed.

• The study reported on a final sample of 18 patients.
• Mean patient age was 55 years in the acupuncture group and 64.9 years in the nurse-led supportive care group.
• Males represented 11% of the intervention group and 6% of the nurse-led supportive care group. Females represented 44% of the intervention group and 39% of the nurse-led supportive care group.
• Cancer sites were breast, rectum, endometrium, cervix, oropharynx, bladder, kidney, lung, cecum, and esophagus, in addition to leukemia and myeloma.

• 80 clinics
• Outpatient setting
• BC Cancer Agency at the Vancouver Island Centre in Victoria (Pain and Symptom Clinic for palliative management of cancer and treatment-related symptoms)

• Patients were receiving end-of-life care.
• The study has clinical applicability for end-of-life and palliative care.

This pilot study was a single-blind, randomized controlled trial.

The Edmond Symptom Assessment System (ESAS) was used to measure any changes in the symptoms experienced by patients before and after the intervention.

The treatment was well tolerated with no significant unexpected side effects. The compliance rate was 90% for acupuncture and 80% for nurse-led supportive care. All nine symptoms (pain, tiredness/fatigue, nausea, depression, anxiety, drowsiness, loss of appetite, lack of well-being, and shortness of breath) were improved immediately after acupuncture, with improvement continuing in six of these symptoms after six weeks. Six symptom scores improved immediately following nurse-led supportive care visits, with all nine symptoms showing improvement after six weeks. Total symptoms were reduced by an average of 22% after each acupuncture visit and by 14% after each nurse-led supportive care visit. ESAS scores at the end of the follow-up period were reduced by 19% for the acupuncture group and 26% for the nurse-led supportive care group. At six weeks after acupuncture, symptoms of pain, nausea, and loss of appetite did not maintain improvement. Only 48% of eligible patients consented to the study, and it was closed due to poor recruitment.

The study suggests that patients can benefit from incorporating acupuncture and supportive interventions to help with symptom management in advanced incurable cancer. Findings suggest that nurse attention provided over the long term benefited patients and that acupuncture may provide some immediate symptom improvements.

• The study had a small sample size, with less than 30 patients.
• No patient blinding with self-report outcome measures may be subject to validity threats.

Nurse-led supportive care can improve symptoms in these patients. These improvements can likely be attributed to increased attention and quality feedback being provided from the nurse to the medical team, who were able to initiate positive changes in medication and other supportive measures.

To evaluate the use of low level laser therapy (LLLT) and aluminum hydroxide for the prevention of oral mucositis in patients with head and neck cancer, and to evaluate the impact of LLLT on pain scores.

Group 1 was given LLLT at 830 nm daily since first day of radiotherapy (RT) to end of therapy prior to RT (RT days only). It was applied to 12 areas of the oral cavity. Group 2 received aluminum hydroxide (AH) suspension (310 mg/5 mL) starting on first day of RT and continued throughout, including weekends. Patients used 10 mL of AH 4 times a day and swallowed and had to avoid eating during the first hour after treatment.

• The sample consisted of 22 patients with an age range of 33–80 years.
• The sample was 91% male and 9% female.
• The majority of head and neck cancer (77.27%) was diagnosed as squamous cell.

This was a single-site, outpatient study conducted in Brazil.

Patients were undergoing the active treatment phase of care.

The study was prospective, comparative, and nonrandomized.

• The National Cancer Institute (NCI) oral toxicity scale was used to evaluate oral mucositis.
• A visual analog scale (VAS) was used to evaluate pain.
• European Organization for Research and Treatment of Cancer's Quality-of-Life Questionnaires (QLQ) (QLQ-c30 and QLQ-H&N35) were used.

Lower oral mucositis (OM) scores were observed in the LLLT group (p = 0.061). More grade III OM was seen in the AH group, and severe OM was delayed in the LLLT group. LLLT pain scores were lower but not statistically significant overall. Quality-of-life (QOL) scores were all higher (i.e., more symptoms) in the AH group.

LLLT was found to be more effective than AH in delaying severe OM; however, more trials are needed.

• The sample size was small with fewer than 30 years.
• No appropriate control group was included. 

Although LLLT was found to be more effective than AH in delaying severe OM, questions exist regrding the best protocols and dosing, as well as how this evidence correlates to other disease types. Additionally, availability of equipment may be an issue.

STUDY PURPOSE: To discuss the treatment of breast cancer-related lymphedema with low-level laser therapy (LLLT), its usefulness, and safety

TYPE OF STUDY: General review/\"semi\" systematic review

• FINAL NUMBER STUDIES INCLUDED = 4
• TOTAL PATIENTS INCLUDED IN REVIEW = 149 (n = 75 treatment, n = 74 control)
• SAMPLE RANGE ACROSS STUDIES: 12–66
• KEY SAMPLE CHARACTERISTICS: All treatment groups received LLLT, and all subjects were breast cancer survivors with BCRL. Ages in both groups were similar, ranging from 45–63 years in the treatment group and 49–65 years in the control group. Baseline excess limb volumes were also similar between the treatment and control groups, although varied measures were used.

PHASE OF CARE: Late effects and survivorship

Three of four studies were able to show statistical significance in limb volume after treatment; however, follow-up times varied. Carati et al. reported a significance of 0.017 (89.7 ml versus 32.1 ml) three-months post-treatment, Kaviani et al. reported a greater reduction in all weeks except one (no statistical reference), Kozanoglu et al. reported a greater reduction with LLLT (p = 0.04 at post-treatment and p = 0.02 at 12 months), and Lau et al. reported a statistically significant reduction at four weeks post-treatment (448.2 to 320.9 ml, p = 0). Two studies reported significance in a decrease in tissue hardness. No improvement in subjective symptoms were reported (pain, range of motion [ROM], heaviness, grip strength); however, Lau et al. reported significantly decreased mean scores on the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in the treatment group (p = 0.04) post-treatment, but they were not statistically significant at four weeks follow-up.

• Limited search
• Low sample sizes
• Control group protocols, treatment protocols, and lymphedema assessment measures were dissimilar in all four studies.
• Quality was assigned to articles; however, evidence levels were not assigned (the authors address this in the article).
• Lack of operational definitions and comparison with standard therapy (CDT) were also limitations.

Nurses need to be knowledgeable of clinical trials involving LLLT and stay current with lymphedema management, as well as educate patients on LLLT.

• Patients were randomly assigned to use either ice chips or room-temperature normal saline (NS) rinses before, during, and after melphalan infusion, two days before peripheral blood stem cell transplantation (PBSCT).
• Patients in the ice chips group were instructed to place approximately 1 oz of crushed ice in the mouth. Ice was allowed to melt and was replenished as soon as it was completely melted. Patients were instructed to start 30 minutes before and continue for 6 hours after the end of the 30-minute melphalan infusion.
• Patients in the saline rinse group were instructed to swish 1 oz of room-temperature normal saline in the mouth and spit it out every 30 minutes.   
• Patients were instructed not to eat or drink anything extremely hot or cold during this period.
• The sample size was set at 40 to provide 91% power at a 0.05 significance level.

• The study reported on 41 randomized patients with 21 assigned to receive ice chips and 20 assigned to receive NS. One patient in the NS group withdrew because the patient wanted ice chips. Therefore, data was collected for 21 patients in the ice chips group and 19 in the NS group.
• Patients had to be 18 years or older with multiple myeloma scheduled to receive single-agent melphalan at 200 mg/m² followed by autologous PBSCT.
• Patients were stratified by age less than or greater than 60 years.

This was a randomized trial.

• Patients completed questionnaires that addressed overall health as well as mouth and throat soreness.
• Patients rated difficulties swallowing, drinking, eating, talking, sleeping, and tasting on a 0–4 scale with 0 = no difficulty and 4 = unable to perform.
• Patients rated mouth and throat soreness on a 0–10 scale.  
• Clinical providers and nurses conducted oral assessments as part of routine care using National Cancer Institute (NCI) common toxicity criteria.

• Fewer patients in the ice chips group (14%) experienced grade 3–4 mucositis than in the NS group (75%) (p = 0.0005).
• Patients in the ice chips group required fewer days of total parenteral nutrition (TPN) than the NS group (2 versus 5.5; p = 0.04).
• Patients in the ice chips group also required fewer days of IV narcotics than the NS group (0 versus 5.5; p = 0.0003).
• No significant difference was found in days of hospitalization.
• Patients in the ice chips group experienced significantly less difficulty with activities of eating, talking, sleeping, and tasting.

• The sample size was small.  
• Some inconsistencies occurred with protocol compliance such as variations in the length of time that ice was used and lack of reporting how long ice was used. Some patients complained of coldness and stopped using the ice chips. Additionally, four patients did not fill out any pain reports or record other activities.

Cryotherapy was associated with improved outcomes. Research is needed to determine the required length of cryotherapy.