Scotté, F., Tourani, J.M., Banu, E., Peyromaure, M., Levy, E., Marsan, S., . . . Oudard, S. (2005). Multicenter study of a frozen glove to prevent docetaxel-induced onycholysis and cutaneous toxicity of the hand. Journal of Clinical Oncology, 23, 4424–4429.
To determine if frozen glove (FG) treatment prevents docetaxel-induced onycholysis and skin toxicity
PHASE OF CARE: Active treatment
The findings suggest that regional cooling may be of benefit to prevent nail toxicity associated with docetaxel treatment.
Regional cooling may have some benefit to reduce the incidence of nail and skin toxicities associated with chemotherapy. Nurses need to be aware of patients who have cold intolerance because of peripheral neuropathies or other reasons, but this appears to be a low-risk intervention that can be helpful.
Scotte, F., Banu, E., Medioni, J., Levy, E., Ebenezer, C., Marsan, S., . . . Oudard, S. (2008). Matched case-control phase 2 study to evaluate the use of a frozen sock to prevent docetaxel-induced onycholysis and cutaneous toxicity of the foot. Cancer, 112, 1625–1631.
To assess the efficacy and safety of cold therapy in the prevention of docetaxel-induced onycholysis and skin toxicity of the foot
Patients wore an Elasto-Gel (Akromed, France) flexible frozen sock (FS) containing glycerin, which has thermal properties that allow its use in cold or hot therapies. The FS covered participants' right foot up to the ankle. The FS was refrigerated for at least three hours at –250 C to –300 C. The FS was worn at each docetaxel infusion for a total of 90 minutes (from 15 minutes before administration to 15 minutes postdocetaxel hourly infusion). Two FSs were used successively (45 minutes each) to maintain coolness. The left foot was not protected and acted as the control.
Prospective, convenience, case-controlled, phase II study of 50 consecutive patients (unblinded)
The FSs led to a significant reduction in nail toxicity with 0% versus 21% (p = 0.002). Overall skin toxicity existed in 2% of FS-protected feet but only 6% of others, which was insignificant (p = 0.18). Time until nail toxicity occurrence for an unprotected foot was associated with the number of cycles (HR of 0.36, 95% confidence interval [0.17, 0.77], p = 0.008). Fifty-eight percent were satisfied and even very satisfied (19%) with the FS protection. Only 2% of patients were dissatisfied because of FS-related cold intolerance.
Cold therapy using FSs significantly reduced the incidence of docetaxel-induced foot nail toxicity, as previously demonstrated on hands using frozen gloves.
Greater than half (58%) the patients were satisfied with wearing the FS, with 19% being very satisfied. This would assist nursing education for the intervention. This intervention is easy to apply with no major side effects. Because the use of FSs did not significantly affect skin toxicity, a study using a type of FS that only covers toes and nails should be tested. This intervention should also be tested with patients receiving other chemotherapy agents associated with nail and skin toxicities.
Scott, A. (2014). Polymeric membrane dressings for radiotherapy-induced skin damage. British Journal of Nursing, 23, S24–S31.
To determine whether a polymeric membrane dressing is effective for radiation skin reactions in patients who scored between 1-2.5 on the Radiation Treatment Oncology Group's (RTOG's) acute radiation morbidity scoring criteria over a four-week period
Observational, quasiexperimental trial
In this setting, because of the results of this small study, Polymem dressings have replaced paraffin gauze and aqueous creams for patients with head and neck cancer. Polymem dressings reduced pain and inflammation, improved sleep patterns, and improved healing rates and quality of life. However, there were many limitations.
Polymeric dressings may reduce the severity of radiodermatitis, promote healing, and reduce associated pain. This report had numerous limitations and does not provide strong evidence for the efficacy of these dressings. Additional, well designed research is warranted.
Scott, D.A., Mills, M., Black, A., Cantwell, M., Campbell, A., Cardwell, C.R., . . . Donnelly, M. (2013). Multidimensional rehabilitation programmes for adult cancer survivors. The Cochrane Database of Systematic Reviews, 3, CD007730.
STUDY PURPOSE: To conduct a systematic review of studies examining the impact of multidimensional rehab programs
TYPE OF STUDY: Meta-analysis and systematic review
DATABASES USED: MEDLINE, EMBASE, CINAHL through February 2012, Cochrane Register of Controlled Trials (CENTRAL)
KEYWORDS: Extensive listing of search terms per database is provided.
INCLUSION CRITERIA: RCT or quasi RCT, interventions included a physical and psychological component, sample is adults who have completed cancer treatment, at least two treatments of the intervention were provided
EXCLUSION CRITERIA: Not specified
TOTAL REFERENCES RETRIEVED: 25,824
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Used a checklist of study characteristics for risk of bias. Nine studies had insufficient information to evaluate risk of bias.
Two studies showed no benefit of the intervention, seven showed benefit in one domain, and three reported significant improvement in physical and psychosocial domains. Three studies specifically reported fatigue outcomes with combinations of CBT or psychoeducational and exercise interventions. All of these had moderate-to-high risk of bias. Duration of interventions that was longer than 12 weeks showed no additional improvement over interventions delivered up to 12 weeks. Interventions delivered face-to-face appeared to be more effective, and additional telephone follow-up “boosters\" improved results. Meta-analysis of physical and mental components of SF36 measures showed no statistically significant overall effect of the intervention. The nature, timing, and duration of interventions varied substantially across studies.
There is insufficient evidence to assess the efficacy of multidimensional rehab programs to improve fatigue in individuals with cancer. Programs with a single focus may be more successful in improving outcomes that are the focus of the intervention. Face-to-face delivery with follow-up boosters appear to be most effective. Beneficial effects seen appear to plateau after about six months.
Meta-analysis was possible on only a few studies. Few studies used objective measures of physical component outcomes. Program adherence by patients was not often reported in studies.
Findings here do not show sufficient evidence to fully evaluate the effectiveness of multidimensional rehab programs to improve fatigue or physical and psychological outcomes for cancer survivors. Such programs may have short-term benefit for some patients, and it appears that interventions delivered face-to-face with follow-up may be more effective.
Scope, A., Lieb, J.A., Dusza, S.W., Phelan, D.L., Myskowski, P.L., Saltz, L., & Halpern, A.C. (2009). A prospective randomized trial of topical pimecrolimus for cetuximab-associated acnelike eruption. Journal of the American Academy of Dermatology, 61, 614–620.
To determine the ability of topical pimecrolimus to reduce the severity of cetuximab-related facial rash.
Patients aged 18 years or older with metastatic colorectal cancer who were on cetuximab treatment and experienced a rash were eligible for randomization. Open-label pimecrolimus 1% cream was to be applied to one side of the face BID for five weeks. Patients completed a daily dairy. Physicians queried patients about side effects and compliance during study visits. Complete skin examinations were performed by dermatologists who were blinded to study applications. Digital photos were used for review. Patients were asked about the presence and perceived severity of rash-associated symptoms on either side of the face. Counts of facial lesions on both sides of the face were performed by blinded dermatologists at weeks 2, 5, and 7. The study took place over five weeks.
Patients were undergoing the active treatment phase of care.
This was a single-blind, randomized, prospective clinical trial, with patients used as their own controls.
Pimecrolimus application did not translate into clinically significant benefit in patients with cetuximab-related facial rash.
Rash may improve without interventions.
Scope, A., Agero, A.L., Dusza, S.W., Myskowski, P.L., Lieb, J.A., Saltz, L., . . . Halpern, A.C. (2007). Randomized double-blind trial of prophylactic oral minocycline and topical tazarotene for cetuximab-associated acne-like eruption. Journal of Clinical Oncology, 25, 5390–5396.
To compare the effectiveness of placebo versus minocycline 100 mg every day for eight weeks, beginning on day 1 of cetuximab infusion, to prevent or reduce cetuximab-induced rash in patients with metastatic colorectal cancer.
To compare the effectiveness of receiving tazarotene cream BID for eight weeks on one side of the patient’s face versus not receiving the topical treatment on the other side of the patient’s face.
Twenty-four patients were randomized to the oral minocycline (100 mg per day) arm, and 24 patients were randomized to the oral placebo arm. Treatment was administered starting on day 1 of cetuximab therapy and continued for eight weeks.
All patients received open-label, topical tazarotene 0.05% cream (Tazorac®) application to one side of their face, starting on day 1 of cetuximab therapy and continuing for eight weeks.
This was a randomized, double-blind, placebo-controlled trial.
Follow-up clinical assessment was completed at weeks 1, 2, 4, and 8, with questionnaires and skin examination, including skin lesion counts and digital photos.
Prophylactic treatment with minocycline appears to significantly decrease the severity of acneform rash during the first eight weeks of cetuximab therapy. Continuation of this therapy beyond eight weeks is not beneficial.
Results suggest that topical tazarotene has no role in the management of cetuximab-induced rash.
Scope, A., Agero, A.L., Dusza, S.W., Myskowski, P.L., Lieb, J.A., Saltz, L., . . . Halpern, A.C. (2007). Randomized double-blind trial of prophylactic oral minocycline and topical tazarotene for cetuximab-associated acne-like eruption. Journal of Clinical Oncology, 25, 5390–5396.
To compare the effectiveness of placebo versus minocycline 100 mg every day for eight weeks, beginning on day 1 of cetuximab infusion, to prevent or reduce cetuximab-induced rash in patients with metastatic colorectal cancer.
To compare the effectiveness of receiving tazarotene cream BID for eight weeks on one side of the patient’s face versus not receiving the topical treatment on the other side of the patient’s face.
Twenty-four patients were randomized to the oral minocycline (100 mg per day) arm, and 24 patients were randomized to the oral placebo arm. Treatment was administered starting on day 1 of cetuximab therapy and continued for eight weeks.
All patients received open-label, topical tazarotene 0.05% cream (Tazorac®) application to one side of their face, starting on day 1 of cetuximab therapy and continuing for eight weeks.
This was a randomized, double-blind, placebo-controlled trial.
Follow-up clinical assessment was completed at weeks 1, 2, 4, and 8, with questionnaires and skin examination, including skin lesion counts and digital photos.
Prophylactic treatment with minocycline appears to significantly decrease the severity of acneform rash during the first eight weeks of cetuximab therapy. Continuation of this therapy beyond eight weeks is not beneficial.
Results suggest that topical tazarotene has no role in the management of cetuximab-induced rash.
Science, M., Robinson, P.D., MacDonald, T., Rassekh, S.R., Dupuis, L.L., & Sung, L. (2014). Guideline for primary antifungal prophylaxis for pediatric patients with cancer or hematopoietic stem cell transplant recipients. Pediatric Blood and Cancer, 61, 393–400.
PURPOSE: To provide healthcare providers with evidence-based recommendations on the use of primary antifungal prophylaxis in children with cancer and undergoing hematopoietic stem cell transplantation (HSCT)
TYPES OF PATIENTS ADDRESSED: Allogeneic and autologous HSCT recipients, children with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS), and pediatric patients with anticipated neutropenia for longer than seven days
RESOURCE TYPE: Evidence-based guideline
PROCESS OF DEVELOPMENT: Literature search was done, and included studies were evaluated using the Grades of Recommendation, Assessment, Development, and Evaluation system. Recommendations were established by a panel discussion. Guidelines then were externally reviewed by another interprofessional expert panel and provided to Canadian pediatric tertiary hospitals for stakeholder review.
DATABASES USED: MEDLINE, EMBASE, Cochrane Collaboration, proceedings of the American Society of Clinical Oncology and American Society of Hematology
KEYWORDS: Not stated
INCLUSION CRITERIA: RCTs involving patients of any age with cancer or undergoing HSCT that compared antifungal agents with another antifungal agent, placebo, or no prophylaxis; no language exclusions
EXCLUSION CRITERIA: Trials involving nonsystemic antifungal treatment
Initially, 7,869 references were retrieved and screened. A final set of 47 studies were included.
The following are strong recommendations.
Additional weak recommendations also are outlined in the guidelines.
Although these guidelines are aimed at pediatric patients, 17 studies included did not include children in the sample.
These evidence-based guidelines clearly recommend primary antifungal prophylaxis in at-risk children. Specific dosages recommended are identified in this reference.
Schwartzberg, L., Jackson, J., Jain, G., Balu, S., & Buchner, D. (2011). Impact of 5-HT(3) RA selection within triple antiemetic regimens on uncontrolled highly emetogenic chemotherapy-induced nausea/vomiting. Expert Review of Pharmacoeconomics & Outcomes Research, 11(4), 481–488.
To assess the likelihood of uncontrolled chemotherapy-induced nausea and vomiting (CINV) events following antiemetic prophylaxis with the 5-HT3 receptor antagonist (RA) palonosetron plus aprepitant or fosaprepitant and dexamethasone versus any of the other 5-HT3 RAs (granisetron, dolesetron, ondansetron) plus aprepitant or fosaprepitant and dexamethasone among single-day, highly emetogneic chemotherapy (HEC) cycles
This was a retrospective analysis of a healthcare claims database from January 2006 through June 2010 using data from International Classification of Diseases book 9 (ICD-9), Current Procedural Terminology (CPT), and pharmacy claims. Investigators evaluated two cohorts. The palonosetron cohort consisted of patients initiating antiemetic prophylaxis with palonosetron plus aprepitant or fosaprepitant and dexamethasone. The \"other 5-HT3 cohort\" consisted of patients receiving any other 5-HT3 RA plus aprepitant or fosaprepitant and dexamethasone.
Patients were undergoing the active treatment phase of care.
This was a retrospective data analysis.
CINV was defined as at least one of the following during days 2–5 post chemotherapy: a diagnosis of nausea or vomiting (ICD-9 code); hydration procedure (CPT code); rescue medication use of any of the following: dexamethasone, diphenhydramine, olanzapine, promethazine, haloperidol, prochlorperazine, lorazepam, or metoclopramide; or antiemetic administration of palonosetron, ondansetron, granisetron, dolasetron and fosaprepitant/aprepitant by oral or IV routes.
A total of 8,018 cycles for the palonosetron cohort and 1,926 cycles for the other 5-HT3-RA cohort were analyzed. Single-day HEC cycles received by the palonosetron cohort had a significantly lower unadjusted risk of an uncontrolled CINV event with a 17% lower risk for palonosetron-administered cycles versus 21% risk for other 5-HT3 RAs (p = 0.0010). Results in the breast cancer and multiple cancer subgroups were consistent with those for the overall population.
This study suggests that all 5-HT3 RAs may not be equivalent in preventing delayed CINV for patients receiving single-day HEC; however, the study design limits the strength of the evidence.
Nurses may want to consider substituting palonosetron as 5-HT3 in antiemetic regimen for single day HEC.
Schwartzberg, L., Morrow, G., Balu, S., Craver, C., Gayle, J., & Cox, D. (2011). Chemotherapy-induced nausea and vomiting and antiemetic prophylaxis with palonosetron versus other 5-HT(3) receptor antagonists in patients with cancer treated with low emetogenic chemotherapy in a hospital outpatient setting in the United States. Current Medical Research and Opinion, 27(8), 1613–1622.
To compare the incidence of chemotherapy-induced nausea and vomiting (CINV) among patients with cancer receiving low emetogenic chemotherapy (LEC) when given an antiemetic prophylaxis treatment of palonosetron versus other 5-HT3 receptor antagonists.
Using the Premier Perspective database, medical records were reviewed to identify patients with cancer who began LEC between the dates of 4/1/2007 and 3/31/2009. The medical records were then examined to determine the type of prophylactic antiemetic therapy prescribed and the patients were divided into two groups: patients prescribed palonosetron and patients prescribed other 5-HT3 receptor antagonists (ondansetron, granisetron, or dolasetron). For the time period encompassing either the first eight cycles of chemotherapy or the first six months of treatment (whichever occurred first), the medical records were examined to determine the rate of acute and delayed CINV events, CINV-related rescue medications used, and CINV-related admissions that occurred during the study follow-up period. Acute events were defined as occurring on day one of a chemotherapy cycle, and delayed events were defined as occurring on days two through seven of a chemotherapy cycle. Outcomes were compared for those patients who were prescribed palonosetron as antiemetic prophylaxis versus those who were prescribed other 5-HT3 receptor antagonists as antiemetic prophylaxis.
A total of 2,439 patients were included in the study.
Mean age was 66.3 years (SD = 12.6 years).
The sample was 54.2% male and 45.8% female.
Cancer diagnoses were lung, gynecological, head and neck, noncolon gastrointestinal, breast, urinary tract, and other or unknown.
All patients were beginning LEC and receiving palonosetron or other 5-HT3 receptor antagonists as antiemetic prophylaxis.
This was a multisite, inpatient and outpatient review of data from more than 600 hospitals from across the United States.
Patients were undergoing the active treatment phase of care.
This was a nonexperimental, retrospective, longitudinal, observational study.
Patients receiving palonosetron experienced significantly fewer CINV events (nausea, vomiting, volume depletion) (p < 0.0001), used significantly fewer antiemetic rescue medications (p < 0.0001), and were emergently/urgently admitted to the hospital significantly fewer times (p < 0.0001) than patients taking other 5-HT3 antagonists.
Among patients with cancer receiving LEC, palonosetron may offer more relief from CINV compared to that offered by older-generation 5-HT3 antagonists.
This was a retrospective study that compared palonosetron against a pool of other 5-HT3 antagonists, with no random assignment to antiemetic medication. This makes it difficult to attribute the study results to the effects of the target “intervention” (palonosetron) and not to other factors.
Palonosetron is a newer 5-HT3 antagonist with different receptor-binding characteristics and a longer half-life than older-generation 5-HT3 antagonists. It may offer more relief from the effects of CINV compared to standard prophylactic emetic therapy. However, one important issue that was noted was that, with LEC, delayed nausea and vomiting was more of an issue than acute. Current guidelines suggest antiemetics that address only nausea and vomiting that occur in the acute phase. Palonosetron could replace older generation 5-HT3 antagonists as standard prophylactic antiemetic therapy, but more research is needed.