To evaluate the safety and efficacy of palonosetron plus dexamethasone for patients receiving multiple-day, highly emetogenic chemotherapy (HEC)

Patients received 0.25 mg IV palonosetron as an infusion 30 minutes before chemotherapy on days 1, 3, and 5 plus dexamethasone 20 mg IV on days 1 and 2, 8 mg orally twice daily on days 6 and 7, and 4 mg orally twice daily on day 8. Given the high receptor-binding affinity and prolonged half-life of palonosetron, this study involved alternate day dosing (days 1, 3, and 5 rather than days 1-3) combined with a standard dexamethasone regimen for multiple-day, cisplatin-based chemotherapy.

The study consisted of 41 patients with germ cell tumors.

This was a nonrandomized trial.

The following data was collected.

• Number of emetic episodes (vomiting and retching)
• Use of rescue medication
• Intensity and duration of nausea on a four-point Likert scale used for nausea intensity
• Evaluation of the effect of nausea on patients’ quality of life via the Osoba nausea module, which assesses five patient-rated items using a four-point scale
• Pharmacokinetic (PK) data

• Descriptive analysis showed complete response (CR) rates.
• The protocol prevented vomiting for most subjects at all timepoints of the study (days 1-9). The lowest percentage came at day 4 when 68% of patients reported no vomiting.
• Some protection against nausea was provided, with 59% or more of patients reporting no or, at maximum, mild nausea at any time on each study day.
• No severe adverse events were noted.
• The most common side effects were headache and constipation.
• No evidence of cumulative toxicity PK data was reported.

• The sample size was small.
• No control arm was included.
• This was a nonrandomized trial.

RESOURCE TYPE: Expert opinion

• DATABASES USED: None
• INCLUSION CRITERIA: None
• EXCLUSION CRITERIA: None

PHASE OF CARE: Active antitumor treatment

Review article

Literature review of common anti-PD-1 checkpoint pathway inhibitors/antibody therapy adverse events. No evidence of quality review provided.

Research is needed on the management of anti-PD-1 checkpoint pathway inhibitors/antibody therapy toxicities.

To investigate the effectiveness of corticosteroids for the treatment of fatigue in patients with advanced cancer

Patients were randomized to receive 16 mg methylprednisolone or placebo orally twice daily for seven days. Study assessments for quality of life levels were done at baseline, day 3, and day 8. Fatigue and appetite loss were evaluated daily.

• N = 34  
• MEDIAN AGE = 69 (range = 46–84 years)
• MALES: 61.8%, FEMALES: 38.2%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types

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

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

Double-blinded, placebo-controlled, randomized, controlled trial

• Visual Analog Scale (VAS) for fatigue and appetite loss
• Quality of Life Questionnaire for Cancer Patients treated with Anticancer Drugs (QOL-ACD)

Fatigue and appetite loss improved in both groups. On day 5, appetite was significantly better with steroid use (p = 0.011). There were no significant differences in adverse events between the groups.

The findings of this study demonstrate that this oral steroid may be helpful for anorexia, but it was not effective for reducing cancer-related fatigue.

• Small sample (< 100)

Oral corticosteroids may improve loss of appetite in patients with advanced cancer. However, steroids were not shown to be helpful in managing the cancer-related fatigue in this study.

To determine if the use of auricular acupressure is effective in relieving nausea and vomiting in patients with breast cancer who are receiving chemotherapy

Random assignment of patients: The experimental group received standard antiemetics for chemotherapy-induced nausea and vomiting (CINV) and auricular acupressure (AA) for five days. The control group received standard antiemetics only. Acute and delayed CINV was measured with the Morrow questionnaire daily for five days after receiving chemotherapy. The questionnaire has 16 items measured with a 7-degree Likert-type scale. Patients self-reported. For the second cycle of chemotherapy, the groups were switched.

• N = 48   
• AGE = 32–65 years
• MEAN AGE = 46.02 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Use of anthracycline, cyclophosphamide, and taxane—high-risk for CINV

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

PHASE OF CARE: Active antitumor treatment

Crossover clinical trial

Morrow (Moro) questionnaire

• Number and intensity of nausea in acute and delayed phases in the AA group was significantly lower than in the control group (p < 0.001).
• The number and intensity of vomiting in the AA group was significantly lower (p < 0.005). 

The use of auricular acupressure was shown to help alleviate CINV when used along with standard antiemetics in patients with breast cancer receiving moderate to high-risk emetogenic chemotherapy.

• Small sample (< 100)
• Risk of bias (no blinding)
• The experimental group's and control group’s intervention was changed in the second cycle.

Auricular acupressure is a safe, noninvasive, easy, patient-administered, nursing-centered, nonpharmacologic treatment and was shown to lower the number and intensity of nausea in both the acute and delayed phases of treatment.

To study the effects of salivary stimulation using chewing gum on oral mucositis (OM) in children undergoing chemotherapy

Patients were randomized to a control group or experimental group. Control patients were given a mouth rinse of nystatin, diphenhydramine, and aluminum three times per day. The test group received the same mouth rinse plus sugar-free chewing gum six times per day for 15 days. The gum was chewed for about 30 minutes.

• N = 130   
• MEAN AGE = 8.5 years
• MALES: 50.8%, FEMALES: 49.2%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Most had hematologic malignancies.

• SITE: Single site   
• SETTING TYPE: Not specified    
• LOCATION: Iran

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

• Randomized, controlled trial

• World Health Organization (WHO) grading system for OM

Prevalence of grade 1 (p < 0.05) and grade 2 (not significant) OM was lower in children who chewed the gum. Grade 3 mucositis was slightly higher among those chewing gum. No difference existed between groups in prevalence of grade 4 mucositis.

Chewing gum for salivary stimulation may help reduce inflammation with low grades of mucositis but shows no overall benefit for more severe mucositis.

• Baseline sample/group differences of import
• Unintended interventions or applicable interventions not described that would influence results
• Chemotherapeutic agents used were not described. Adherence to interventions for mouth rinses as well as use of chewing gum are not described.

Chewing sugar-free gum to increase salivary stimulation is a low-risk intervention that may help in low-grade mucositis cases but appears to have no overall efficacy in reducing the prevalence or severity of mucositis in children receiving chemotherapy. Further research regarding the potential role of salivary stimulation for the prevention or management of OM would be beneficial.

200 mg of oral posaconazole was started three times daily on patients on the first day after their chemotherapy ended. Treatment was started prophylactically and was independent of a specific cycle of chemotherapy (i.e., some patients started after cycle 1, some started after cycle 2). A total of 76 chemotherapy cycles were included among these 40 patients.

• Forty participants with an age range of 38–76 years.
• 65% were male, 35% were female
• Key disease characterisitcs included acute myelogenous leukemia (30 of the participating patients), acute myelogenous leukemia after MDS conversion (9 patients), and one patient with chronic myeloid leukemia with biphenotypic blast crisis.

A single site in Heidelberg, Germany.
 

Active treatment

Retrospective, observational study.

• Development of fungal Infection in patients receiving posaconazole as prophylaxis.   
• Development of sepsis in patients receiving posaconazole as prophylaxis.
   

23 patients enrolled in the study developed pneumonia, with 13 being possible invasive fungal disease and 1 being proven aspergillosis. Single-agent posaconazole as prophylaxis was interrupted in 25 of the 40 enrolled patients due to various causes; one patient was unable to swallow due to mucositis, two developed adverse reactions. One third of the patients (25 cycles of the 76 studied) had systemic therapy of different types started during the study time period because of signs and symptoms of fungal infection or due to adverse events.

Based on the findings of the study, posaconzole may show promise for prevention of fungal infection in the immunocompromised patient, although it cannot be relied on as monotherapy for all patients due to the limitations of it being only PO and the use of other systemic anti-fungal prophylaxis. More studies are needed with posaconazole to determine its effectiveness as sole prophylaxis.

Some patients included were receiving additional prophylactic treatment other than posaconazole, making it hard to determine which drug was the most effective in prevention of invasive fungal infection.

Posaconazole may be an effective treatment prophylactically for fungal infection if patients are able to take oral medications, but further studies are needed to determine how effective it can be. The fact that it only comes as an oral product limits the population that may benefit.

STUDY PURPOSE: To summarize evidence regarding rehabilitation interventions to address problems of cancer survivors

TYPE OF STUDY: Systematic review

DATABASES USED: PubMed, EMBASE, CINAHL, Scopus, Google Scholar

INCLUSION CRITERIA: Effectiveness of treatment that could be provided by rehab professionals, subjects 18 years or older, cancer survivors (defined as having completed primary treatment). Reports on only systematic reviews and RCTs, though these were not identified as criteria.  

EXCLUSION CRITERIA: Pharmaceutical, surgical, or radiological interventions

TOTAL REFERENCES RETRIEVED: Not stated

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: No quality rating applied. Appears to have very few studies in multiple areas.

• FINAL NUMBER STUDIES INCLUDED =  56
• SAMPLE RANGE ACROSS STUDIES, TOTAL PATIENTS INCLUDED IN REVIEW: Not provided
• KEY SAMPLE CHARACTERISTICS: Not provided

PHASE OF CARE: Transition phase after active treatment

• Reviews seven systematic reviews and six RCTs regarding impact of exercise on fatigue
• States that results confirm a positive effect on fatigue for rehab therapies
• Some of these studies included acupuncture, counseling, and mindfulness-based stress reduction therapy

Evidence supports the effectiveness of exercise-based interventions in managing fatigue among cancer survivors.

• No quality rating of studies
• Limited studies included, and it is not clear how these were selected
• Study findings are grouped by problem, rather than synthesizing evidence related to specific interventions (for example, combining effects of exercise and acupuncture interventions)

The review provides limited information to assess efficacy of specific interventions. Studies reviewed here do not add further to the body of knowledge overall, and the report is aimed at identifying interventions that can be provided by rehabilitation professionals rather than synthesis of intervention evidence.

• The author described the pathophysiology of palmar-plantar erythrodysesthesia (PPE) and strategies to prevent or minimize PPE.
  • Pegylated liposomal doxorubicin leaks out of abnormally formed (i.e., tumor-related), damaged, or dilated blood vessels.
  • Because the hands and feet contain a high concentration of blood vessels, they are particularly susceptible to PPE.
  • Patients should avoid any undue pressure to their skin caused by running, gardening, crossing their legs, leaning on their elbows, or wearing shoes or clothing that is too tight or rubs the skin.
  • In addition, patients should avoid activities that dilate the blood vessels, such as sitting in the sun, ingesting hot fluids or food, and taking hot showers or baths.
• The author provided a nursing algorithm for the management of hand-foot syndrome.
  • Provide patient education prior to chemotherapy.
  • Review causes and symptoms of PPE.
  • Avoid undue pressure to the skin (i.e., wear loose clothing and shoes).
  • Avoid dilation of blood vessels (e.g., hot showers, sun).
  • Report all symptoms.
• Manage symptoms of PPE as required.
  • Advise patients to use cold packs.
  • Advise patients to elevate extremities to reduce edema.
  • Suggest topical emollients (e.g., lanolin creams, Bag Balm^®).
  • Suggest burn ointments (e.g., silver sulfadiazine).
  • Initiate administration of oral pyridoxine (100–300 mg per day).
  • Prescribe systemic pain medications, as required.
  • Teach wound care to prevent infection.
  • Reinforce patient education, emphasizing prevention.

Multiple interventions can be implemented to prevent or minimize PPE. Patient education is an integral component to promote self-care. Key teaching points include strategies for patients to avoid pressure and friction on their skin because those behaviors may increase uptake of the affecting drug into the blood vessels of the hands and feet.

Routine assessment for PPE should include examination of the palms and soles for redness, swelling, flaking, blisters, rash, sores, cracks, and fissures. Based on nursing assessment, dose modifications may be needed.

To verify the efficacy of cryotherapy plus low level laser therapy (LLLT) on oral mucositis (OM) in patients receiving high-dose melphalan chemotherapy

Prior to chemotherapy, patients were examined by a dentist who performed prophylaxis, eliminated any oral infections, and provided oral hygiene instructions. All patients received basic oral care, consisting of gargling with alcohol-free mouthwash and brushing of teeth. Daily LLLT was given from the day after chemotherapy was begun until engraftment. Study group patients also received cryotherapy in addition to LLLT with ice chips for five minutes before infusion, during melphalan infusion, and then for 30 minutes after infusion. Mucositis was evaluated daily. Patients who received cryotherapy were compared to historical controls who received only oral hygiene and historical controls who received hygiene plus LLLT.

• N = 104
• MEAN AGE = 56.3 years
• AGE RANGE = 6–73 years
• MALES: 70.2%, FEMALES: 29.8%
• KEY DISEASE CHARACTERISTICS: Patients had multiple tumor types, most had multiple myeloma, and all were undergoing ablative chemotherapy for HCT.
• OTHER KEY SAMPLE CHARACTERISTICS: The majority had autologous HCT.

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

• PHASE OF CARE: Active antitumor treatment

• Prospective with historical cohort comparisons

• World Health Organization (WHO) oral mucositis scale

Fifty-four patients had LLLT plus cryotherapy, 17 had LLLT, and 33 had only oral hygiene. All patients had some degree of OM. Those who received LLLT plus cryotherapy had the highest prevalence of grade 1 mucositis and lowest prevalence of grade 2 or greater (p < 0.001). The duration of OM was highest in the control group, who had only oral hygiene (p < 0.001).

The combination of LLLT and cryotherapy was associated with the lowest severity of OM compared to controls and patients receiving LLLT alone.

• Baseline sample/group differences of import
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)
• Significant group differences in age, chemotherapy regimens used, and diagnoses, which could have influenced results

The addition of oral cryotherapy to LLLT for patients undergoing ablative chemotherapy with melphalan prior to HCT demonstrated greater efficacy in reducing the severity of OM. Both LLLT and cryotherapy have demonstrated efficacy for preventing severe OM. This study shows that the addition of oral cryotherapy with melphalan infusions can further reduce this complication. Nurses should employ cryotherapy in appropriate patients such as those receiving high-dose melphalan, and advocate for the concomitant use of LLLT.

PURPOSE: To review effective strategies to assist nurses in caring for patients receiving sorafenib, with the focus on those adverse effects the group felt were most difficult to manage—hand-foot syndrome, diarrhea, fatigue, and oral complications

TYPES OF PATIENTS ADDRESSED: Patients receiving sorafenib for renal cell or hepatocellular cancer

RESOURCE TYPE: Evidence-based guideline

DATABASES USED: PubMed, Cochrane Library, and hand-searching of the Clinical Journal of Oncology Nursing and American Society of Clinical Oncology website     

KEYWORDS: Side effect general terms, and specific terms for each side effect (e.g., altered taste, hand-foot syndrome); disease-related search terms included renal cancer, cancer of the kidneys, hepatocellular carcinoma, and liver cancer

INCLUSION CRITERIA: Evidence base included wider literature regarding the management of similar adverse events in patients with other types of cancer and other types of antitumor therapy. No other specific criteria were stated.

EXCLUSION CRITERIA: Not stated
 

• PHASE OF CARE: Active antitumor treatment            
• APPLICATIONS: Late effects and survivorship

Out of 2,469 initial citations retrieved, 37 were included for review. No specific quality evaluation of citations was done due to the nature of the literature, with few clinical trials. No description of the group process used is provided. Findings from citations reviewed were outlined and a review of the literature was provided, but no actual synthesis of evidence exists. Noted is that most evidence in this area is from experience.

Recommendations for mucositis include oral care, amifostine, and antibiotic paste for prophylaxis. For symptom management, recommendations include ice chips, topical lidocaine solutions, sage tea and baking soda oral rinses, and topical solution containing aloe vera, and advising patient to avoid tobacco, alcohol, and spicy foods, mucosal coating agents (e.g., Gelclair®), hydrolytic enzymes, and treatment interruption. For diarrhea, recommendations are patient education, loperamide, diphenoxylate, cholestyramine, probiotics, tincture of opium, and antidiarrheal agents, and avoidance of lactose, high roughage, fatty and spicy foods, fruit juice, and caffeine. For hand-foot syndrome, recommendations include use of emollients, wearing gloves, and avoiding constrictive footwear, hot water, urea- or salicylate-containing creams, and treatment interruptions. For fatigue, recommendations include encouraging activity, maintaining normal work and social schedules, providing supportive care, and considering antidepressants, methylphenidate, sleep medication, and treatment-free intervals.

This review adds nothing new to the limited body of evidence in this area, and does not include a huge body of literature related to the management of fatigue and diarrhea symptoms. Most evidence reviewed was of low quality and expert opinion. No process by which the group evaluated the evidence strength in order to make full recommendations is described, and the result is generally a listing of previously documented opinions related to the management of these symptoms.

This review provides recommended assessments and management approaches that are at the level of expert opinion only.