Protective effects of doxepin cream on radiation dermatitis in breast cancer: A single arm double-blind randomized clinical trial.

Abstract

AIMS:

Breast cancer is the most frequently occurring cancer in women. Lumpectomy followed by radiotherapy is suggested to be as effective as a total mastectomy. Radiation-induced dermatitis often occurs as a result of breast radiotherapy. Recent studies suggest that doxepin has promising anti-inflammatory properties. This study was undertaken to evaluate the effects of doxepin therapy on radiation dermatitis.

METHODS:

A double-blind randomized clinical trial was launched from 2016 to 2017, with a total of 48 patients who had undergone breast-conserving surgery and received postoperative radiation therapy. Radiotherapy was applied 5 days per week for 5 weeks. Adverse dermatological effects were evaluated by a physician at the beginning of the fifth week of radiotherapy and the patients were then randomly assigned (1:1 ratio) to receive either doxepin (5%) or placebo cream for 7 days.

RESULTS:

There were no significant differences in the dermatitis grade between doxepin and placebo groups at baseline (P > .5). The occurrence of acute dermatitis (grade 2 or higher) was significantly lower with the use of doxepin than with placebo (P ≤ .0001, Zα = 1.96 at 95% confidence interval).

CONCLUSION:

Doxepin cream prevents dermatitis grade 2 or higher during post-operative breast irradiation. Doxepin cream is easy to use, affordable and prevents pain and irritation.

• Authors: Laleh Shariati, Alireza Amouheidari, Hajar Naji Esfahani, Alireza Abed, Shaghayegh Haghjooy Javanmard, Ismail Laher, Ahmad Ghasemi, Golnaz Vaseghi
• Journal: British journal of clinical pharmacology (Br J Clin Pharmacol) Vol. 86 Issue 9 Pg. 1875-1881 (09 2020) ISSN: 1365-2125 [Electronic] England
• PMID: 32040868 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2020 The British Pharmacological Society.

Chemical References

• Doxepin

Topics

• Breast Neoplasms (radiotherapy)
• Double-Blind Method
• Doxepin (pharmacology)
• Female
• Humans
• Mastectomy
• Radiodermatitis (prevention & control)
• Single-Blind Method