Evaluation of the effect celecoxib against radiotherapy induced acute toxicities in the patients with prostate cancer compared with placebo group.

The purpose of this study was to assess the effect of celecoxib against radiation induced acute bowel and urinary toxicities in patients treated with radiotherapy for prostate cancer. All patients recently diagnosed with localized prostate cancer at the radiotherapy department of Mahdiyeh Center in Hamedan، Iran were evaluated for eligibility of participant in study. Referred Patients to local curative radiotherapy with external beam radiotherapy (EBRT) were invited to take part in the project. Forty prostate cancer patients undergoing external beam radiotherapy were enrolled to receive either placebo (n=20) or celecoxib(n=20). Inclusion and exclusion criteria included histologically confirmed prostate cancer، cases were candidates for definitive or postoperative external beam radiotherapy and have not radioghraphic evidence of distant metastasis. The patients received external beam radiotherapy up to 70 Gy at daily fractions of 1.8-2 Gy . The patients received oral celecoxib or placebo 200 mg twice daily. The first celecoxib or placebo administration 3 hr before each radiotherapy fraction and the second، 12 hr after than first consumption. RTOG based gastrointestinal (GI) and genitourinary (GU) acute toxicity scoring was performed pretreatment، at least once weekly during radiotherapy and once 1 month after the end of treatment. Before starting therapy، at 4 week of the therapy and 1 month after completion of the treatment blood samples were taken. The measurements contained complete blood count، coagulation parameters، creatinine level، serum urea، AP، AST، ALT and total bilirubine. Randomization was carried out by administrative personnel outside the trial in a double blind fashion. All participants and researcher were blinded to group assignment Random.

Shahid Beheshti University of Medical Sciences