Randomized Double-blind Placebo-controlled Trial of Celecoxib for the Prevention of Skin Toxicity in Patients Receiving Radiation Therapy for Breast Cancer.

BACKGROUND: The skin toxicity-induced by ionizing radiation may limit the duration of treatment and may lead to discomfort in quality of life of patients during radiotherapy.

OBJECTIVE: The purpose of this randomized, placebo-controlled, double-blind study was to investigate the preventive effect of oral administration of celecoxib (CLX) on the acute radiation- induced skin toxicity in patients with breast cancer.

METHODS: Sixty breast cancer patients were randomly assigned to use CLX (400 mg per day) or placebo capsules during radiotherapy. Radiation-induced dermatitis was classified according to the radiation therapy oncology group (RTOG) criteria, as well as pain and itching were scored according to the VAS (Visual Analogue Scale) for six weeks of treatment. Breast swelling was evaluated through increase in the size of the breast during radiotherapy.

RESULTS: Oral administration of CLX capsule during and after radiotherapy reduced significantly radiation-induced itching and pain in patients with breast cancer. CLX reduced the frequency of increased breast size caused by radiotherapy in patients as compared with placebo; however, this difference was statistically not significant. Patients who received CLX had insignificantly skin dermatitis when compared with placebo group.

CONCLUSION: However, CLX was unable to reduce the dermatitis caused by ionizing radiation; it significantly reduced itching and pain in patients during radiotherapy. CLX may have beneficial effects in the quality life of breast cancer patients for treatment.