A Prospective Randomized Controlled Trial to Study the Role of Sulfasalazine in the Prevention of Acute Gastrointestinal Toxicities in Patients of Carcinoma of the Cervix Receiving Concurrent Chemoradiation

Abstract

The present study aimed to evaluate the effectiveness of sulfasalazine in preventing acute gastrointestinal (GI) toxicities in patients with cervical carcinoma receiving concurrent chemoradiation. This prospective randomized controlled study was conducted at the Department of Radiotherapy from November 2016 to April 2018. A total of 60 eligible patients (30 in arm A and 30 in arm B) were enrolled in the study. Patients in arm A received 5,000 cGy of external beam radiotherapy (EBRT) in 25 fractions concurrently with chemotherapy using cisplatin (40 mg/m2 weekly) and tablet sulfasalazine (1 g twice a day). Patients in arm B received 5,000 cGy of EBRT in 25 fractions concurrently with chemotherapy using cisplatin (40 mg/m2 weekly) without any prophylactic medication. The acute GI toxicities assessed in this study included diarrhea, abdominal pain, tenesmus, and rectal bleeding. The chi-squared test was employed to compare the toxicity grades in the two arms. The collected data were analyzed using Statistical Package for Social Sciences (SPSS) version 21, with statistical significance considered at p < 0.05. The results showed a significant decrease in the incidence of grade 2 or higher diarrhea in the study arm compared to the control arm. Additionally, there was a decrease in the incidence of grade 1 or higher abdominal pain in the study arm. A decrease in the incidence of grade 1 or higher tenesmus was also observed, although the difference was not statistically significant. Rectal bleeding decreased significantly. Sulfasalazine was found to be a cost-effective and safe method for reducing the incidence of radiation-induced acute GI toxicities in cervical carcinoma patients undergoing radiotherapy.