Related Experiment Videos
A randomized double blind placebo controlled multicenter study of mesalazine for the prevention of acute radiation
Background And Purpose:
Symptoms of acute radiation enteritis (ARE), dominated by diarrhea, occur in more than 70% of patients receiving pelvic irradiation. Eicosanoids and free radicals release have been implicated in the pathogenesis. Mesalazine (5-ASA) is a potent inhibitor of their synthesis in the mucosa and could therefore be of some interest in preventing ARE.
Patients And Methods:
The study was performed in six radiotherapy units in France who agreed on standardized irradiation procedures. One hundred and fifty-three patients planned for external beam radiotherapy to the pelvis > or = 45 Gy for prostate (n = 97) or uterus (n = 54) cancer were randomized on a double blind basis to receive prophylactic 5-ASA (4 g/day Pentasa) or placebo. Patients with concomitant chemotherapy were excluded. Prostate and uterus cancers were chosen since these centropelvic tumors require a similar radiotherapy protocol during the first step of treatment and involve a comparable volume of small intestine. The symptoms of ARE and their severity were assessed every week during irradiation, and 1 and 3 months after its end. All patients followed a low fiber and low lactose diet. End points were diarrhea, use of antidiarrheal agents, abdominal pain, and body weight. Effficacy was evaluated using intention to treat.
Results:
(means +/- SD) Groups did not differ for age (mean 64 +/- 9 years), sex, tumor site, or irradiation procedure. During irradiation, diarrhea occurred in 69% and 66% of the 5-ASA and placebo groups, respectively (chi2, P = 0.22). Curves of survival without diarrhea did not differ between groups (logrank P = 0.09). Severity of diarrhea did not differ between groups except at d15 where it was significantly more severe in the 5-ASA group (ANOVA P = 0.006). Duration of diarrhea did not differ (22 +/- 15 days in both groups, P = 0.88). Abdominal pain was less frequently reported in the 5-ASA group at d28 (34% vs. 51%, P = 0.048). Use of antidiarrheal agents and body weight did not differ between groups.
Conclusion:
Mesalazine 4 g/day did not decrease the symptoms of ARE.
Insights
Mesalazine (5-ASA) did not prevent acute radiation enteritis (ARE) symptoms like diarrhea in pelvic radiotherapy patients. While abdominal pain was less frequent with 5-ASA, overall effectiveness in reducing ARE symptoms was not demonstrated.
Area of Science:
- Oncology
- Gastroenterology
- Radiotherapy
Background:
- Acute radiation enteritis (ARE) is a common side effect of pelvic irradiation, primarily causing diarrhea.
- Eicosanoids and free radicals are implicated in ARE pathogenesis.
- Mesalazine (5-ASA) inhibits synthesis of these inflammatory mediators.
Purpose of the Study:
- To evaluate the efficacy of mesalazine (5-ASA) in preventing acute radiation enteritis (ARE) in patients undergoing pelvic radiotherapy.
- To assess the impact of 5-ASA on diarrhea, abdominal pain, and body weight during and after treatment.
Main Methods:
- A double-blind, randomized study involving 153 patients with prostate or uterus cancer receiving pelvic radiotherapy (> or = 45 Gy).
- Patients received either 4 g/day of 5-ASA (Pentasa) or a placebo.
- Symptoms of ARE were assessed weekly during irradiation and at 1 and 3 months post-treatment.
Main Results:
- Diarrhea incidence did not differ significantly between the 5-ASA (69%) and placebo (66%) groups.
- Diarrhea severity was higher in the 5-ASA group at day 15.
- Abdominal pain was reported less frequently in the 5-ASA group at day 28 (34% vs. 51%).
Conclusions:
- Prophylactic mesalazine (5-ASA) at 4 g/day did not reduce the overall symptoms of acute radiation enteritis.
- Further research may be needed to explore alternative or adjunctive therapies for ARE.