Use of Axillary Deodorant and Effect on Acute Skin Toxicity During Radiotherapy for Breast Cancer: A Prospective Randomized Noninferiority Trial
Received 30 October 2008; received in revised form 16 December 2008; accepted 19 December 2008. published online 27 March 2009.
Purpose
To prospectively determine the effect of deodorant use on acute skin toxicity and quality of life during breast radiotherapy (RT).
Methods and Materials
Before breast RT, 84 patients were randomly assigned to the deodorant group (n = 40) or the no-deodorant group (n = 44). The patients were stratified by axillary RT and previous chemotherapy. Toxicity evaluations were always performed by the principal investigator, who was unaware of the group assignment, at the end of RT and 2 weeks after completion using the Radiation Therapy Oncology Group acute skin toxicity criteria. Symptoms of acute skin toxicity (i.e., discomfort, pain, pruritus, sweating) and quality of life were self-evaluated. For each criterion, the point estimate of rate difference with the 95% one-sided upper confidence limit was computed. To claim noninferiority owing to deodorant use, the 95% one-sided upper confidence limit had to be lower than the noninferiority margin, fixed to 12.8%.
Results
In the deodorant vs. no-deodorant groups, Grade 2 axillary radiodermatitis occurred in 23% vs. 30%, respectively, satisfying the statistical criteria for noninferiority (p = .019). Grade 2 breast radiodermatitis occurred in 30% vs. 34% of the deodorant vs. no-deodorant groups, respectively, also satisfying the statistical criteria for noninferiority (p = .049). Similar results were observed for the self-reported evaluations. The deodorant group reported less sweating (18% vs. 39%, p = .032). No Grade 3 or 4 radiodermatitis was observed.
Conclusion
According to our noninferiority margin definition, the occurrence of skin toxicity and its related symptoms were statistically equivalent in both groups. No evidence was found to prohibit deodorant use (notwithstanding the use of an antiperspirant with aluminum) during RT for breast cancer.
∗Département de Radio-Oncologie, L'Hôtel-Dieu de Québec, Centre Hospitalier Universitaire de Québec, Québec, QB, Canada
†Centre de Recherche de L'Hôtel-Dieu de Québec, L'Hôtel-Dieu de Québec, Centre Hospitalier Universitaire de Québec, Centre de Recherche en Cancérologie de l'Université Laval, Québec, QB, Canada
Reprint requests to: Valérie Théberge, M.D., Département de Radio-Oncologie, L'Hôtel-Dieu de Québec, Centre Hospitalier Universitaire de Québec, 11, Côte du Palais, Québec, QB G1R 2J6 Canada. Tel: (418) 691-5264; Fax: (418) 691-5268
Presented as an oral presentation at the 2008 Annual Canadian Association of Radiation Oncology Meeting, Montréal, Canada and 2008 Annual Association de Radio-Oncologues du Québec Meeting, St-Sauveur, QB, Canada; and as a poster presentation at the 2008 Annual American Society for Therapeutic Radiology and Oncology Meeting, Boston, MA and 2008 Annual European Society for Therapeutic Radiology and Oncology Meeting, Göteborg, Sweden.
ABSTRACT