To determine the effects of ginger on chemotherapy-induced nausea and vomiting (CINV) in women receiving adjuvant anthracycline for breast cancer

Patients were randomly assigned to control and treatment groups. Women in the intervention group consumed 500 mg of powdered ginger mixed with yogurt twice daily after an initial dose 30 minutes prior to chemotherapy. Both groups received triplet antiemetic therapy. Patients were followed for five days and were asked to record episodes of vomiting and retching and to evaluate their nausea using a numeric 10-point scale four times per day in a diary. The numeric scale also was used on the first day of chemotherapy to collect baseline data. Patient diaries were collected at the end of the five-day study period.

• N = 60  
• MEAN AGE = 48.5 years (range = 49–58 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All patients were receiving adjuvant anthracycline, were currently receiving triplet antiemetics, and experienced grade 3 or higher CINV during the previous cycle of chemotherapy.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Turkey

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• Numeric Rating Scale (NRS) for nausea
• Patient diary 

Nausea severity was significantly lower in the experimental group after the intervention on study days 2–5 (p = 0.0001). The number of vomiting episodes also was lower in the experimental group on some study days (p < 0.05).

The use of ginger as an adjuvant to triplet antiemetics among women receiving anthracycline-based chemotherapy resulted in lower acute and delayed nausea severity.

• Small sample (< 100)
• Risk of bias (no blinding)

Advances in antiemetic drugs have substantially improved the prevention and control vomiting in the acute and delayed phases of CINV. However, the prevention of nausea has been difficult to achieve. Findings from this study suggest that the use of ginger in combination with triplet antiemetics can be beneficial in reducing the severity of nausea.

To evaluate the effectiveness of prophylactic tetracycline on afatinib-induced skin toxicities

Afatinib was given after disease progression with chemotherapy. Patients receiving afatinib were randomly assigned to receive general dermatological recommendations (control group) or 250 mg tetracycline every 12 hours in addition to general recommendations. All were receiving 40 mg afatanib every day until disease progression or toxicity. Dosage of afatinib was reduced to 30 mg daily for grade 3 or prolonged grade 2 toxicity. General recommendations provided to all patients were brief baths with lukewarm water, use of sunscreen, emollient creams, hypoallergenic soap, and fingernail care. Study assessments were conducted at baseline, week 2, and week 4 by a blinded assessor.

• N = 90
• MEAN AGE = 57 
• MALES: 26.7%, FEMALES: 73.3%
• KEY DISEASE CHARACTERISTICS: All had lung cancer.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Mexico

PHASE OF CARE: Active antitumor treatment

• Single-blind, randomized, controlled trial

• National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Most common toxicities were rash (65.6%), pruritus,(42.2%), mucositis (41.1%), paronychia (33.3%), skin fissures (24.4%), folliculitis (24.4%), and trichomegaly (22.2%). No grade 5 toxicities existed. Rash incidence was 75.5% in the control group versus 55.5% in the tetracycline group (relative risk [RR] = 0.4, p = 0.046), and rash severity of grade 2 or higher was 15.6% in the tetracycline group compared to 35.6% among controls (RR = 0.35, p = 0.03). Incidence of paronychia was lower in the tetracycline group, but group differences were not statistically significant. No other differences existed between groups in skin effects, and no differences existed between groups in the proportion of patients who required afatinib dose reductions. Most patients developed maximum rash intensity between weeks 1 and 4 of treatment. No relationship existed between rash incidence or severity and general disease outcomes.

Prophylactic tetracycline was effective in reducing the incidence and severity of rashes associated with afatinib use.

• Small sample (< 100)

Very limited evidence exists for effective interventions to prevent or treat skin toxicities associated with epidermal growth factor receptor inhibitor (EGFRI) administration. Although the use of antibiotics has been suggested, currently little research demonstrates their efficacy. This study begins to fill that evidence gap, showing that tetracycline can be effective in reducing the incidence and severity of skin toxicity. This is a relatively low-cost and generally safe intervention to reduce adverse skin effects in patients receiving EGFRIs.

To evaluate the efficacy of low level laser therapy (LLLT) for the prevention and treatment of radiotherapy-induced oral mucositis in patients with oral cancer

Patients with primary oral cancer were randomized to the laser group or a control group. All patients had oral prophylaxis before starting radiation therapy, and all had the same oral care during treatment. All patients were evaluated daily for pain severity, functional impairment, and oral mucositis. The clinical exams were performed by a single examiner. All the laser treatments were administered by one operator. The treatment consisted of use of a laser scanner for the first eight days followed by treatment to six areas on the right and left sides of the oral cavity for 25 days.

• The study reported on 24 patients, ages 55–59 years old.
• The sample was 50% female and 50% male.
• Patients were newly diagnosed with primary oral cancer limited to the oral cavity
• Patients received 66 Gy in 33 fractions, 5 days per week for 6.5 weeks. No patients experiencing treatment delays were included in the study.

This was a single site, inpatient and outpatient study conducted at Kasturba Medical College of Manipal University in Karnataka, India.

This was a randomized controlled trial.

• A numeric rating scale was used to measure severity of oral pain.
• To evaluate patient need for supplemental analgesics, the World Health Organization (WHO) analgesic ladder, date of initiation, and  duration of analgesic use were recorded.
• Functional impairment was recorded.
• A scale was used to assess severity of dysphagia.
• Mucositis severity was assessed daily by one examiner using the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) scoring system.

Pain increased gradually and was the greatest at the end of seven weeks. The laser group had a statistically significant lower level of pain than did the control group (p < 0.03). In week 3, the laser group had grade I functional impairment, while the control group progressed to grade II and III functional impairment, with one individual having grade IV impairment. Overall, the laser group had lower mucositis severity than the control group (p = 0.033).

Prophylactic laser therapy during radiation therapy can reduce the severity of mucositis, as well as the severity of functional impairment and pain.

• The control group had a small sample size of fewer than 30 patients.
• The article did not state what the control group procedure involved (e.g., sham treatment).

This form of laser therapy is effective in the prevention of severe mucositis, but it is very high tech and requires special equipment and highly trained personnel.

The primary objective was to find which interventions, if any, were effective in preventing central venous catheter (CVC)-related infections in children with cancer. The secondary objective was to examine the effectiveness of each intervention in the subgroups of (a) implanted venous external catheters, (b) hematologic versus nonhematologic malignancies, and (c) in those receiving hematopoietic stem cell transplantation (HSCT) versus no HSCT.

Databases searched were the Cochrane Central Register of Controlled Trials (2008), MEDLINE (January 1950–January 2009), EMBASE (January 1980–January 2009), and CINAHL (January 1982–March 2009), as were reference lists from relevant articles and international conference proceedings (2004–2008).

Reviews examined were randomized, controlled trials and quasi-randomized, controlled trials of children (younger than 18 years) with cancer who had long-term tunneled CVCs with a CVC infection-prevention intervention other than anticoagulants, systemic antibiotics, and antibiotic lock techniques versus no intervention, placebo, or other intervention to prevent CVC-related infections.

Studies with interventions to treat other catheter-related complications were excluded.

Twenty-eight total references were retrieved.

For dichotomous outcomes, risk ratio and 95% confidence interval (CI) were used to express the estimate of effect; for continuous outcomes, weighted mean differences, standard deviation (SD), and 95% CI were used to summarize the data for each group; and for rare events, rate ratio as a summary statistic and meta-analysis of rate ratios via a generic inverse-variance approach were used.  

The initial total search yielded 876 citations, 216 of which were duplicates. From this, 28 full-text articles were reviewed and three were kept for final analysis. The overall study quality was low.

• After all exclusions, three studies (with 793 participants) were examined.
• Sample range across studies was 103 to 577 patients.
• Patients younger than 22 years with hematologic and nonhematologic malignancies, and one study with HSCT recipients, who had long-term internal or external CVCs were included. Interventions were monthly flushes of 3 mL of prophylactic urokinase-heparin (total doses of 5,000 IU of urokinase) versus heparin alone (total doses of 300 units of heparin); two weekly catheter flushes with urokinase alone (5,000 IU/mL) versus heparin alone (100 units per mL); and transparent catheter dressing changes every 15 days versus every four days (HSCT study).

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for pediatrics.

Meta-analysis for the comparison of catheter flushing with urokinase (with or without heparin) versus heparin alone demonstrated an effect on the catheter-associated infection (CAI) rate with the rate ratio of CAI rate = 0.72 (95% CI [0.12, 4.41]) with use of urokinase in adults. One study reviewed reported an incidence of CAI of 2.6 per 1,000 CVC days with urokinase and 3.9 per 1,000 CVC days with heparin (p = 0.04). Studies involving different frequencies of dressing changes were difficult to analyze because adherence to every 14-day change was very low.

There were fewer CAIs with urokinase flushes, with or without heparin versus heparin alone, suggesting that urokinase use in catheter flushes may be beneficial. These findings are limited by the wide CI in findings and the fact that how CAI was defined for this systematic review was not described. No firm conclusions can be drawn from this review regarding urokinase, but the results suggest that further research in this area is warranted, although the difference between the groups was not statistically significant. There were no differences between groups who received dressing changes every 15 days versus every four days regarding the premature removal of the catheter due to infection. Catheter-related infections were not evaluated in the dressing change study, and adherence to the dressing change intervention was poor.

The results highlight need for clear and consistent outcomes definitions to further the research in this area.

Databases searched were AMED, EMBASE, MEDLINE, and PubMed via the Ovid platform and CINAHL via EBSCO.

Search keywords were oncology, chemotherapy, radiotherapy, strength training, aerobic exercise, walking program, physical activity, and fatigue.

Studies were included if they reported 

• An acute or rehab hospital setting
• A controlled trial
• An outcome measure of fatigue
• Sufficient exercise intensity to have a physiologic effect.

Studies were excluded if they reported additional diversional interventions.

Initially, 2,954 studies were retrieved. After exclusions, there was a final set of five studies. The PEDro scale was applied for evaluation of study quality.

• The final five trials included 269 patients with various cancer types.
• Sample sizes ranged from 22 to 104 patients.

• Overall study quality was low, with scores being an average of 4.6 out of 10 possible points.
• Four trials were included in the meta-analysis. Findings for fatigue showed a standardized mean difference of -0.22 (95% confidence interval [-0.62, 0.08]; p = 0.13).
• The most common fatigue measures were the Brief Fatigue Inventory (BFI) and visual analog scale (VAS).
• All interventions involved aerobic exercise.
• There were no between-group effects seen for other symptoms analyzed.

This review showed no significant effect of aerobic exercise interventions for fatigue outcomes in hospitalized patients with cancer. As this study only included hospitalized patients, the findings may not be applicable in other patient groups.

The study was limited by the small number of included trials, with most having small sample sizes.

Effectiveness of exercise for fatigue may vary greatly depending on the phase of care and time in the cancer disease trajectory at which the intervention is provided. Lack of significant positive findings here may be related to the timing of the intervention with all patients in acute or rehabilitation hospitals.

To test the effectiveness of a brief intervention using a cognitive and behaviorally oriented approach on symptoms of fatigue.

Patients were randomly assigned to the intervention or usual care control group. The intervention included three individual face-to-face, sixty-minute sessions that coincided with chemotherapy treatment schedules. These were aimed at clarifying meanings, setting goals, educating patients about cancer-related fatigue, developing and discussing coping strategies, and cognitive restructuring. Sessions were audiotaped to ensure treatment fidelity. Study assessments were performed at baseline (cycle three of chemotherapy), the end of treatment, four weeks after the end of treatment, and nine months after study entry.

• In total, 50 patients (40% male, 60% female) were included.  
• Mean age was 59.1 years (standard deviation = 11.5 years).
• Colorectal cancers were the most common. Multiple other tumor types were included
• Of the patients, 80% had stage III or IV disease, and 76% had at least one other comorbid condition.

• Single site 
• Outpatient 
• United Kingdom

Patients were undergoing the active antitumor treatment phase of care.

The study was a randomized, controlled trial.

• 100-mm visual analog scale (VAS) for global fatigue
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Fatigue outcome measure designed for the study
• Multidimensional Fatigue Inventory (MFI)
• Hospital Anxiety and Depression Scale (HADS)

VAS fatigue scores were significantly lower in the experimental group at Time 2, end of treatment (p = 0.03), but not at any other time point. EORTC physical functioning scores were higher in the experimental group at the end of treatment (p = 0.001) and at four weeks after treatment ended (p = 0.02). There was an overall trend over time favoring the experimental group; however, the trend was not significant and was smaller when data were controlled for medical conditions and HADS scores. No data for the nine-month time after treatment were provided.

Findings suggest that a cognitive-behavioral approach intervention can be beneficial in reducing fatigue during the short term after cancer treatment.

• The study had a small sample size, with less than 100 participants.
• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• Subject withdrawals were 10% or greater. 

Findings suggest that cognitive-behavioral approach interventions to restructure thinking, set goals and coping strategies, and improve self-efficacy may be helpful in reducing fatigue immediately after chemotherapy treatment. This evidence is not strong, given the study limitations here, but the findings are potentially promising.

To test the effectiveness of propolis as a mouthwash to reduce chemotherapy-induced oral mucositis

Patients were randomized to receive a propolis mouth rinse (30% extract) or sterile water placebo rinse. Patients were to swish 5 ml of the rinse in the mouth for 60 seconds, gargle, and expectorate. Rinses were used three times daily for seven days.

• N = 40   
• AGE = Not reported
• MALES: Not reported  
• FEMALES: Not reported
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Patients with head and neck cancer receiving chemotherapy and radiation therapy

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Iran

PHASE OF CARE: Active antitumor treatment

Double-blind, randomized, controlled trial

World Health Organization (WHO) mucositis grading

By day seven, erythema, wounding, and general mucositis grades were lower in the propolis group (p < 0.006). Mucositis grades were lower in the propolis group.

The findings suggest that propolis mouth rinses may be helpful to manage oral mucositis in patients with head and neck cancer receiving chemotherapy and radiation therapy. Well designed research is needed to confirm these findings.

• Small sample (< 100)
• No demographic information was provided, and the chemotherapy regimens used were not adequately described. There is no information about other aspects of oral care that were used.

This study report has multiple flaws and provided only weak evidence of the potential effectiveness of propolis for the reduction of oral mucositis. Well designed research is needed to further evaluate the potential effects of this intervention.

To study the efficacy of aprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC) for colorectal cancer

Patients with advanced or recurrent colorectal cancer were treated with standard MEC regimens including FOLFOX, XELOX, OR FOLFIRI and received either standard antiemetic therapy with 5-HT₃ receptor antagonist (RA) plus dexamethasone or aprepitant regimen including 5-HT₃ RA plus reduced-dose dexamethasone plus aprepitant. Patients were followed from the initiation of chemotherapy through day 5 using patient diaries to record emetic episodes, nausea, or rescue antiemetics in 24-hour intervals.

• N = 117 Japanese and Australian adults with recurrent or advanced colorectal cancer stratified based on Performance status 
• MEAN AGE = 63.48 years in standard group, 66.46 years in aprepitant group
• MALES: 56%, FEMALES: 44%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Patients with dvanced or recurrent colorectal cancer receiving MEC

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

PHASE OF CARE: Active antitumor treatment

Multicenter, phase II, open-label, randomized, parallel, comparative study

The outcomes in both groups were analyzed using chi-squared tests for primary end points, secondary end points, and patients characteristics by treatment group. Two-sided sample t tests were used when appropriate. P < 0.05 was considered to be a statistically significant difference.

The percentage of patients with complete response in the overall phase was 79.6% in the standard group versus 79.7% in the aprepitant group. The acute phase was 94.9% complete response in both groups, and the delayed phase was 79.6% versus 79.7%. The overall incidence of adverse events were similar in both groups.

No significant differences existed between the standard treatment and aprepitant regimen in terms of complete suppression of vomiting, nausea, and time to treatment failure. This study demonstrates that aprepitant in combination with a 5-HT₃ RA and reduced dose of dexamethasone is well tolerated and effective for preventing CINV associated with MEC in patients with colorectal cancer.

The addition of aprepitant to standard antiemetic therapy for MEC in patients with colorectal cancer is well tolerated and effective for control of CINV, but the lack of significant difference suggests that the added cost of an additional medication is not warranted.

Patients were enrolled to test vitamin E as prophylaxis against chemotherapy-induced peripheral neuropathy.

Patients were randomly divided into groups assigned to receive chemotherapy treatment with (group I) or without vitamin E supplementation (group II). Group II served as control. Patients assigned to group I received alpha-tocopherol (i.e., vitamin E) orally at a dose of 300 mg per day twice daily during chemotherapy and as long as three months after chemotherapy was completed.

• The total sample consisted of 40 patients treated with six courses of cumulative cisplatin, paclitaxel, or their combination regimens for a nonmyeloid malignancy.
• The final sample size was 31.
• Exclusion criteria included a history of neuropathy, systemic diseases such as diabetes, lupus, HIV, alcohol abuse, and those who had received chemotherapy in the past.

The study had a pilot, randomized, controlled, open label with blind assessment design.

The clinical evaluation of neuropathy was based on a modified Neurologic Symptom Score (NSS) and Neurologic Disability Score (NDS). NSS selected symptoms such as weakness, numbness, or pain, scoring as present (1) or absent (0). Clinical signs (i.e., cranial nerves function; joint position, pin prick, and vibration sensation; muscle strength and deep tendon reflexes) were assessed using a modified version of NDS ranging from 0 (no deficit) to 4 (absence of function/severest deficit). Electrophysiologic examination included motor conduction of ulnar and peroneal nerves. Measures were taken at baseline and repeated after the third and sixth cycles as well as three months after cessation by the same neurologist.

Vitamin E supplementation significantly decreased the incidence of neurotoxicity, with 25% of patients receiving Vitamin E experiencing chemotherapy-induced peripheral neuropathy compared to 73.3% in the control group.

This pilot study with a small sample size and many variables assessed make achieving a statistically significant result by chance alone more likely.

Small sample size

To assess the efficacy and safety of celiac plexus neurolysis in reducing pancreatic cancer pain; to identify adverse effects and differences associated with various techniques of celiac plexus neurolysis

• Databases searched were Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Gateway, and EMBASE. In addition, investigators manually searched reference lists and the proceedings of relevant international professional groups.
• Search keywords were celiac plexus, nerve block, pancreatic cancer, and pain.
• Studies were included if they
  • Involved celiac plexus block implemented through a surgical approach or EUS.
  • Were randomized controlled trials that included a minimum follow-up of four weeks.
  • Were published in English.
  • Dealt with pain secondary to pancreatic cancer.
• Studies were excluded if they were reported in an abstract rather than a full article or if they dealt with pain due to chronic inflammation rather than pain relating to cancer of the pancreas.

The initial search retrieved 102 studies. Investigators reviewed the studies in terms of risk of bias. Investigators performed a meta-analysis on studies that they selected to include.

• The final sample of studies consisted of six studies involving 358 patients.
• Range of sample size, across studies, was 20–137.

• At four weeks, mean pain score difference according to a visual analog scale was –0.42 with 95% confidence interval (CI) –0.71 through –0.13 (p = 0.004) in favor of celiac block. At eight weeks, investigators noted significant heterogeneity.
• Opioid consumption was lower with celiac plexus block, with a mean difference at four weeks of –34.33 (95% CI –44.43 through –24.24, p < 0.00001).
• Adverse events were more likely to occur in control groups. The most common adverse events were diarrhea and constipation. These effects may have been associated with the higher opioid consumption of patients taking placebo.
• The number of studies was insufficient to allow researchers to evaluate the efficacy of different block implementations.

Celiac plexus block appears to be a safe and effective means of reducing bone pain associated with pancreatic cancer. Results show that celiac plexus block has a slight but statistically significant advantage over usual analgesic treatment. Investigators noted that the studies included in the analysis had some identified risk of bias. Three of the studies were blinded; three were not. The studies Arcidiacono et al. reviewed were the same studies that Yan and Myers reviewed in 2007.

Data are insufficient to allow researchers to evaluate the differences between CT-guided and posterior percutaneous celiac plexus block techniques.

Nurses should be aware of celiac plexus block as a means of pain management in patients with cancer of the pancreas. Nurses should advocate for the patient and inform him or her of potential treatment options. Findings of this meta-analysis are based on follow-up at four weeks, and results showed significant heterogeneity at eight weeks. This suggests that efficacy may not be sustainable over the long term. Further research, including long-term follow-up, is needed.