Wohlrab, J., Bangemann, N., Kleine-Tebbe, A., Thill, M., Kummel, S., Grischke, E.M., . . . Luftner, D. (2014). Barrier protective use of skin care to prevent chemotherapy-induced cutaneous symptoms and to maintain quality of life in patients with breast cancer. Breast Cancer, 6, 115–122. 

To test the effectiveness of a topical application of a niacinamide-containing, barrier-protective preparation in women with breast cancer undergoing treatment with anthracyclines or taxanes

This prospective, randomized, reference-controlled crossover study began on the first day of chemotherapy. One study group (group 1) received the test preparation (TP) for six weeks then standard care (SC) for six weeks. Group 2 started with six weeks of SC then crossed over to six weeks of TP. TP consisted of a shea butter lipophilic cream containing 4% niacinamide and thermal spring water from La Roche-Posay as the hydrophilic phase (Lipikar Baume AP^®; La Roche-Posay Laboratoire Pharmaceutique, La Roche-Posay, France). TP was applied twice daily on the whole body. SC consisted of patients' usual body care. This was used as the control arm. Data were collected for 12 weeks.

• N = 73
• AGE RANGE = 25–77 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients who were diagnosed with breast cancer and who were scheduled to receive taxane or anthracycline chemotherapy in an adjuvant or neoadjuvant setting with or without trastuzumab
• OTHER KEY SAMPLE CHARACTERISTICS: Patients could not have dysfunctional skin barrier signs, atopic or psoriatic skin history, or have been prescribed or using over-the-counter compounds with vasoactives, anti-inflammatory agents, diuretics, or medications affecting lipid metabolism.

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

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

Multicenter, prospective, randomized, reference-controlled crossover study

• The Dermatology Life Quality Index (DLQI): Six DLQI subscales were included in the analysis.
• Symptoms of pruritus, dryness, and skin irritability were quantified using a Visual Analog Scale (VAS).

Total DLQI scores after six weeks were not significantly different. There was a significant difference on the “symptoms and feelings” DLQI subscale after week 4 (p = .06). Secondary parameters of pruritus (p = .034), dryness (p = .0002), and irritability (p = .0312) revealed significant differences for TP after six weeks.

Anthracyclines and taxanes cause dry, itchy skin. Total DLQI scores indicated that the treatment was not superior to the control in preventing skin toxicities associated with anthracycline and taxane therapy in women with breast cancer. Results from the VAS indicated that the experimental treatment may improve pruritus, dryness, and skin irritability. No safety concerns were raised by participants in this trial.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Measurement/methods not well described
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: This study, although randomized, was not blinded. Measurement tools were discussed but not provided. Dropout rates were caused by patients stopping chemotherapy. This study was not generalizable due to the homogeneity of the sample.

Skin and cutaneous side effects from chemotherapy affect the quality of life of patients dealing with cancer diagnoses. The ability to suggest proactive interventions gives healthcare providers the opportunity to promote patient independence and show an understanding of patients' physical and social needs. Without untoward effects, it would seem appropriate to suggest niacinamide-containing creams as a possible preventive treatment for skin care during chemotherapy with anthracyclines or taxanes to decrease dryness, pruritus, and skin irritability in this population. Nurses should share the limitations of this study when discussing the evidence it produced. Research on this compound in patients with other diagnoses using these chemotherapy agents could strengthen the level of evidence.