To summarize existing adult and pediatric data on central venous catheter (CVC)-related bloodstream infections (BSIs) and identify models of care that can improve pediatric oncology outcomes.

Databases searched were PubMed, CINAHL, and Google Scholar (1998–2010).

Keywords searched were CVC, BSI, and pediatric oncology.

Patients were included if they

• Had a central venous access device.
• Had the device in place 48 hours prior to development of symptoms and/or culture.
• Had a confirmed culture unrelated to another site.
• Reported a fever of higher than 100.4ºF.

No exclusion criteria were specified.

• The total number of studies included was 24. 
• The studies provided 8,682 total cases; the sample range was not relevant.
• Patients were either adult or pediatric in terrtiarty hospitals or intensive care units. 
• Diagnoses involved were not described, although pediatric oncology was included.
   

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

Strategies to reduce CVC-related BSIs reported were summarized.  In regard to insertion site selection and catheter type, some data supported the use of an externalized catheter versus a port in children.  Use of impregnated catheters in children is controversial. Evidence-based guidelines (CVC “bundles”) have been shown to be effective to reduce BSI rates.

Bundles include

• Hand hygiene
• Full barriers at insertion
• Chlorhexidine skin cleansing
• Avoiding the femoral site
• Removal of all unnecessary catheters.

For CVC education, studies showed that annual education enhanced adherence to policy.

Findings suggested that the implementation of CVC care bundles was effective in reducing CVC-related BSI rates.
 

Most studies involved critical care patients and not necessarily those with cancer who would be more immunocompromised.  There was limited research information on pediatric oncology cases.

This review supported the use of CVC care bundles to reduce rates of CVC-related BSIs.  Findings suggested that regular and repeated education on CVC care can improve adherence to care protocols.

To compare the efficacy and cost-effectiveness of a single dose of pegfilgrastim to daily injections of filgrastim after peripheral blood stem cell transplant (PBSCT).

Patients were randomized to receive either a single 6-mg dose of pegfilgrastim five days after PBSCT reinfusion or daily 5-µg/kg doses of filgrastim from day 5 posttransplantation until the resolution of neutropenia.  Patients were followed for 100 days after transplantation.  Complete blood cell counts were obtained daily during hospitalization and every two weeks thereafter.

• One hundred fifty patients (57.3% male, 42.7% female) were included.
• Median age was 55 to 59 years (range 19–75) across groups.
• All patients had either lymphoma or multiple myeloma; 50% underwent transplantation as a first-line therapy and 98% were either in complete or partial remission. 
• Patient conditioning was done without any full body radiation.

• Multi-site  
• Multiple settings 
• France

Patients were undergoing the active antitumor treatment phase of care.

This was a randomized, unblinded, open-label study.

• Duration of febrile neutropenia, absolute neutrophil count (ANC) <0.5 G/L, and temperature >38°C
• National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0
• Mean hospital day costs and drug costs across participating centers were used for cost-effectiveness analysis.  Differences in cost and effectiveness were plotted per patient to determine incremental cost ratios.

Patients on pegfilgrastim had a shorter duration of ANC <1 g/l, fewer days with fever, shorter hospital stay, and fewer days of antibiotic therapy.  Significant differences for individual outcomes were not analyzed but were incorporated in the cost-effectiveness analysis.  Severe mucositis was observed in 25% of patients taking pegfilgrastim versus 20% of those taking filgrastim.  Mean total cost with pegfilgrastim was $32,326 compared to $35,373 with filgrastim.  Cost-effectiveness analysis showed that the probability that pegfilgrastim is less costly and more effective than filgrastim is 62%.

Findings suggested that there is no substantial cost difference between a single dose of pegfilgrastim versus daily filgrastim in patients undergoing PBSCT and that the pegfilgrastim regimen may be more cost-effective.

• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results*

* Although the costs of antifungals and antibiotics were provided, no information was provided regarding whether routine prophylaxis was also provided to patients in the sample.

Both of these colony-stimulating factor preparations have been shown to be effective.  This study provided some initial information that the single dose regimen of pegfilgrastim is more cost-effective.  The need to give fewer injections to achieve the same result can be of benefit to patients.  Further evidence to confirm the findings of this study would be beneficial.  Additional study regarding the most cost-effective formulations and schedules of these agents is warranted.

PURPOSE: To review an article from a non-peer-reviewed journal on the control of bleeding in malignant fungating wounds in advanced cancer

• Eight references in the article with reference to control of bleeding

• Gentle dressing removal of malignant wounds, using saline if the dressing adheres to the wound
• Use nonadherent dressings or moist wound products.
• Use direct pressure for 10–15 minutes when bleeding does occur; ice packs assist in control.
• Use hemostatic agents if bleeding does not stop (i.e., absorbable gelatin, collagen, alginate dressings).
• Gauze saturated with topical vasoconstrictors (i.e., epinephrine) are an option.
• Apply sucralfate paste as an option.

• Lack of evidence
• The journal is reputable but is not peer-reviewed.

To determine if frozen glove (FG) treatment prevents docetaxel-induced onycholysis and skin toxicity

• Patients received docetaxl 75mg/m².
• FG = ElastoGel (84400 APT Cedex, Akromed, France), a gel-filled sock that can supply heat or cold that was used to cover the hand to the wrist
• The glove was refrigerated for at least three hours (–25 to –30 C), then placed on right hand for 90 minutes (intervention) 15 minutes before infusion, 1 hour of infusion, and 15 minutes after infusion. Two FGs were used sequentially to maintain a consistently low temperature.
• The left hand was unprotected (control).
• Onycholysis and skin toxicity were assessed at each cycle via National Cancer Institute's (NCI's) Common Terminology Criteria of Adverse Events (CTCAE) and were photo documented.

• N = 45 patients
• MEDIAN AGE = 62 years
• AGE RANGE = 41–80 years
• MALES: 78%, FEMALES: 22%
• KEY DISEASE CHARACTERISTICS: Prostate cancer (58%), non-small cell lung cancer (24%), breast cancer (11%), other cancers (6%)
• OTHER KEY SAMPLE CHARACTERISTICS: Docetaxel regimen (monotherapy, combination therapy in 58% of sample); 31% had prior chemotherapy.

• SITE: Multicenter    
• SETTING TYPE: Not stated   
• LOCATION: Paris and Poitiers

PHASE OF CARE: Active treatment

• Phase-II, multicenter, matched-case controlled trial

• Onycholysis/skin toxicity was assessed at each cycle by a medical investigator and repeated by another observer using NCI CTCAE, version 2. 
• Ad-hoc rating scale: Patient global comfort assessment

• Median number of docetaxel cycles was six
• Median cumulative docetaxel dose was 810 mg
• Overall occurrence of nail toxicity was lower in those with the cooling glove (11% versus 51%, p = 0.0001). None of the hands with the cooling glove developed higher than grade 1 nail toxicity. Overall skin toxicity occurred in 24% of the glove-protected hands compared to 53% of the control hands (p = 0.0001).

The findings suggest that regional cooling may be of benefit to prevent nail toxicity associated with docetaxel treatment.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Questionable protocol fidelity

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.

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.

• N = 48   
• MEDIAN AGE = 62 years (range = 36–80 years)
• MALES: 36 (75%), FEMALES: 12 (25%)
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Variety of tumor types; undergoing docetaxel at 70–100mg /m² every three weeks for one-hour infusions, alone or in combination therapy
• OTHER KEY SAMPLE CHARACTERISTICS: No prior taxane therapies, absence of skin and nail disorders, life expectancy of at least three months and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. All patients provided written informed consent.

• SITE: Single site   
• SETTING TYPE: Not specified    
• LOCATION: French center

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

Prospective, convenience, case-controlled, phase II study of 50 consecutive patients (unblinded)

• Two-sample Wilcoxon matched-pairs rank test adjusted for tied values to determined statistical difference
• Kaplan–Meier and log-rank methods were used to estimate and compare differences in time to toxicity occurrence.
• Common Terminology Criteria for Adverse Events (CTCAE), version 3, for onycholysis and skin toxicity
• Four-point satisfaction scale for patient comfort

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.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)
• Findings not generalizable
• Convenience sample of consecutive patients

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.

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

• N = 20
• MEAN AGE = 56.8 years
• MALES: 17 (85%), FEMALES: 3 (15%)
• KEY DISEASE CHARACTERISTICS: Primary diagnosis was head and neck cancer
• OTHER KEY SAMPLE CHARACTERISTICS: 30% were diagnosed with squamous cell carcinoma of the larynx

• SITE: Single-site (assumed, not clearly described)
• SETTING TYPE: Cancer center
• LOCATION: Mount Vernon Cancer Centre, Middlesex, United Kingdom

• PHASE OF CARE: Active treatment

Observational, quasiexperimental trial

• RTOG Morbidity Scoring Scale
• Wong and Baker FACES^® Scale
• Malnutrition Universal Screening Tool (MUST)
• World Health Organization's (WHO's) Analgesic Ladder

• 13 (65%) RTOG = 2
• 5 (25%) RTOG = 2.5
• 2 (10%) RTOG = 1
• 0 (0%) RTOG = 3 or 4

• Patient response and clinical observation: Within the first week of treatment, skin reactions were reduced in both dry and moist desquamation.
• First week: Eight patients healed.
• Second week: Five patients healed.
• Third week: Two patients healed but stopped using dressing.
• Fourth week: Two patients were healing but had not completely healed.
• 15% of patients' skin reactions healed.

• Patient response and clinical observation: Within the first week of treatment, skin reactions were reduced in both dry and moist desquamation.

• Through days 1 to 14, pain levels declined with mean self-reported pain scores being 6–7 (day 1) and 1–2 (day 14)
• During the first 14 days, patients took a combination of codeine, co-codamol, and paracetamol.
• Patients reported a significant reduction in wound pain and increased comfort with dressings usage.

• No patients were taking sedative medications or practicing relaxation techniques. By the sixth day, patients that kept pain diaries reported sleeping four to eight hours out of a 24 hour day.
• Journal diaries reported increased sleeping hours.

• Journal diaries reported that patients and their caregivers were able to change the dressings.

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.

• Small sample (< 30)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Selective outcomes reporting
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: Patients and clinicians should have been trained in assessment as there may have been discordance in reporting. This method was not clearly described.

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.

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.

• FINAL NUMBER STUDIES INCLUDED = 12 (6 studies that used the SF36 for outcome measures were included in meta-analysis)
• SAMPLE RANGE ACROSS STUDIES: 24–543
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,669
• KEY SAMPLE CHARACTERISTICS: Prostate and breast cancer were most prevalent patient types. One study involved head and neck, and four studies included multiple cancer types.

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.

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.

• The study reported on a sample of 16 patients with metastatic colorectal cancer.
• Patients were aged 18 years or older.
• Gender was not reported.

• Single site
• Outpatient
• New York City Hospital in New York

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.

• Baseline evaluation    
• Skin assessment by dermatology
• Digital photography of faces
• Clinical and skin assessment at weeks 2, 5, and 7
• Counts of facial lesions at weeks 2, 5, and 7
• Patient-completed daily study diary

• A statistically significantly greater decrease in lesion counts existed for the treatment versus observational sides of patients' faces by week 2. This result was maintained by week 5, but was nonsignificant after stopping cream by week 7.
• No significant differences existed in rash severity.
• No difference existed in the frequency of patient-assessed itch, burning, and dryness or perceived degree of facial erythema between treated and untreated sides of the face, per patients’ report.
• Of note, a bilateral decrease in rash severity was reported at week 7.

Pimecrolimus application did not translate into clinically significant benefit in patients with cetuximab-related facial rash.

• The sample size was small (fewer than 30 patients).
• The study was not placebo controlled.

Rash may improve without interventions.

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.

• The study reported on a sample of 48 adult men and women with stage IV metastatic colorectal cancer, who were preparing to initiate treatment with cetuximab.
• Mean patient age was 61 years (range 39–83 years).

• Single center
• Memorial Sloan-Kettering Cancer Center

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.

• Initially, 48 patients were randomized in this study. At the end of the eight-week trial, 35 patients were included in the final analysis (18 patients in the minocycline arm and 17 patients in the placebo arm).
• A significant overall difference existed in log lesion counts between the minocycline arm (fewer lesions) and the placebo arm (p = 0.005). The difference was apparent by week 1, peaked at weeks 2 and 4, and tapered by the end of the study (week 8).
• At week 4, a decreased proportion of patients in the minocycline arm reported moderate-severe itch compared to those in the placebo arm.
• Patients in the minocycline arm trended toward decreased frequency of moderate-severe rash compared to those in the placebo arm. Those differences diminished by week 8.
• In four patients in the placebo arm (8%), cetuximab treatment was interrupted because of grade 3 dermatologic adverse events. Cetuximab treatment was not interrupted for any patients in the minocycline arm.
• Topical treatment with tazarotene did not translate into a meaningful clinical benefit.
• Of the 43 patients available for at least one clinical evaluation, 14 (33%) discontinued tazarotene prematurely as a result of local irritation.
• Three additional patients (7%) reported stopping tazarotene after one month because of subjective lack of efficacy compared to the control side of the face.
• In a review of facial photography at week 4 (n = 39), no difference existed in rash severity between the tazarotene and observation sides of the face (n = 34, 87%), and the rash was assessed as more severe in four patients (10%) who received tazarotene.

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.

• The sample size was small (48 at the start of the study; reduced to 35 by the end of eight weeks).
• The measurement tool or method used to grade rash symptoms was not described.
• A combination of interventions was used; therefore, determining the effectiveness of the individual interventions is difficult.

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.

• The study reported on a sample of 48 adult men and women with stage IV metastatic colorectal cancer, who were preparing to initiate treatment with cetuximab.
• Mean patient age was 61 years (range 39–83 years).

• Single center
• Memorial Sloan-Kettering Cancer Center

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.

• Initially, 48 patients were randomized in this study. At the end of the eight-week trial, 35 patients were included in the final analysis (18 patients in the minocycline arm and 17 patients in the placebo arm).
• A significant overall difference existed in log lesion counts between the minocycline arm (fewer lesions) and the placebo arm (p = 0.005). The difference was apparent by week 1, peaked at weeks 2 and 4, and tapered by the end of the study (week 8).
• At week 4, a decreased proportion of patients in the minocycline arm reported moderate-severe itch compared to those in the placebo arm.
• Patients in the minocycline arm trended toward decreased frequency of moderate-severe rash compared to those in the placebo arm. Those differences diminished by week 8.
• In four patients in the placebo arm (8%), cetuximab treatment was interrupted because of grade 3 dermatologic adverse events. Cetuximab treatment was not interrupted for any patients in the minocycline arm.
• Topical treatment with tazarotene did not translate into a meaningful clinical benefit.
• Of the 43 patients available for at least one clinical evaluation, 14 (33%) discontinued tazarotene prematurely as a result of local irritation.
• Three additional patients (7%) reported stopping tazarotene after one month because of subjective lack of efficacy compared to the control side of the face.
• In a review of facial photography at week 4 (n = 39), no difference existed in rash severity between the tazarotene and observation sides of the face (n = 34, 87%), and the rash was assessed as more severe in four patients (10%) who received tazarotene.

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.

• The sample size was small (48 at the start of the study; reduced to 35 by the end of eight weeks).
• The measurement tool or method used to grade rash symptoms was not described.
• A combination of interventions was used; therefore, determining the effectiveness of the individual interventions is difficult.