A randomised controlled trial of radiotherapy and metronidazole versus radiotherapy alone in anaemia patients with advanced cervical cancer in Mulago Hospital.

Abstract

INTRODUCTION: Cancer of the cervix accounts for 60% of gynaecological cancers in Uganda and 40% of patients on radiotherapy in Mulago Hospital, Kampala, Uganda. Only 15.1% are medically eligible for chemoradiation yet many of these cannot afford it. A randomised controlled trial was initiated evaluating metronidazole and radiotherapy in the treatment of anaemicpatients with advanced uterine cervical cancer. OBJECTIVE: To determine the efficacy and safety of metronidazole as an adjunct to radiotherapy compared to radiotherapy alone for the treatment of anemic patients with advanced cancer of the cervix as measured by clinical response. PATIENTS AND METHODS: A total of 38 participants who met the inclusion criteria were randomised between January 2009 and April 2009. Participants were randomised to either standard radiotherapy alone (RT) or standard radiotherapy and additional administration of metronidazole (RT+MX). A total dose 50Gy was delivered in an overall time of five weeks. In the study arm, patients received 1g of metronidazole and those in the arm received 500mg of paracetamol (placebo). Both drugs were administered per-rectum 30 minutes before external beam radiotherapy on alternate days during the entire course of external beam therapy. RESULTS: After follow up of five weeks, there was a 24.6% (p=0.001) reduction of tumour volume among the patients who received RT+MX compared to RT. Metronidazole did not increase toxicity. There was however no significant difference in time to cessation of symptoms in both arms. CONCLUSION: We conclude that addition of metronidazole to radiotherapy significantly increases short tern local tumour volume reduction among anaemic patients with advanced cancer of the uterine cervix without any increase in major toxicity but doesnot reduce the time to cessation of vaginal bleeding and abnormal vaginal discharge. Further analysis and follow up are needed to evaluate if this benefit will translate into prolonged survival.