Clinical trial · Interventional
Radiotherapy + Metronidazole vs Radiotherapy Alone In Improving Treatment Outcomes in Advanced Cervical Cancer in Uganda
A Randomized Clinical Trial of Radiotherapy and Metronidazole Versus Radiotherapy Alone in Anaemic Patients With Advanced Cervical Cancer In Mulago
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of the study was to determine whether there was a difference in the effectiveness of Radiotherapy alone compared with Radiotherapy plus Metronidazole in the treatment of women with advanced cancer of the cervix in Mulago hospital. It was a randomized controlled trial composed of 38 women altogether, with one group composed of randomly selected women with advanced cancer of the cervix treated with radiotherapy alone and the other group composed of similar women but treated with radiotherapy and metronidazole.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Carcinoma | Cervical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy plus metronidazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy plus metronidazole
- description
- Participants in the intervention arm received 1gm (2 suppositories) of metronidazole per rectum 30 minutes before radiotherapy for every other radiotherapy session with two rest days of Saturday and Sunday. The standard radiotherapy regimen for advanced cancer of the cervix composed of two phases of radiotherapy was used; phase 1 was tele-therapy via parallel-opposed portals from Co-60 radiation source, with a total dose of 50 Gy given in 25 fractions of 2 Gy/day for five weeks. The patients were then given a break of 1-4 weeks before getting the second phase of treatment. Phase 2 was brachy-therapy from a Cs-137 source, whereby a single dose of 30Gy was delivered at point A at a rate of 2.55 Gy/ hour for 7 hours and 50 minutes, via a uterine Tandem and two vaginal Ovoids.
- interventionNames
- Drug: Radiotherapy plus metronidazole
- type
- PLACEBO_COMPARATOR
- label
- Radiotherapy alone
- description
- Participants in the control arm received 500mg (two suppositories) of paracetamol as a placebo on similar days. This was in addition to the standard radiotherapy administration in two phases as described above.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with cancer of the cervix who had histologically proven stage IIB to IVB cancer of the cervix. * Women with cancer of the cervix who had been assessed and found fit for radiotherapy * Women with cancer of the cervix who had Hb 12g/dl and below. Exclusion Criteria: * Women who were already on metronidazole treatment for other reasons other than radio sensitization * Women who had a history of neuropathy
References
Publications (0)
Data not yet available