Radiotherapy + Metronidazole vs Radiotherapy Alone In Improving Treatment Outcomes in Advanced Cervical Cancer in Uganda

NCT01937650 | Completed Phase 2 DMC

• 1 other identifier: 2009-059
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Cervix Carcinoma

Keywords

Radiotherapy, metronidazole, cervical cancer, Mulago

Outcome Measures

Primary Outcomes (1)

• Percentage reduction in tumor volume as compared to baseline

  To determine the efficacy and safety of metronidazole as an adjunct to radiotherapy in anemic patients with advanced cervical cancer in improving treatment outcomes in Mulago Hospital, Kampala, Uganda.

  After three months - end of study

Secondary Outcomes (1)

• To determine the safety of metronidazole and radiotherapy as measured by number of complications in both arms

  At interim analysis

Study Arms (2)

Radiotherapy plus metronidazole

ACTIVE COMPARATOR

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.

Drug: Radiotherapy plus metronidazole

Radiotherapy alone

PLACEBO COMPARATOR

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.

Interventions

Radiotherapy plus metronidazole DRUG

Metronidazole was added to the standard radiotherapy that is routinely used.

Also known as: Arm A

Radiotherapy plus metronidazole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women who were already on metronidazole treatment for other reasons other than radio sensitization
• Women who had a history of neuropathy

Sponsors & Collaborators

• Makerere University: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiotherapy; Metronidazole

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Peter Kibuuka, MBChB

  Makerere University

  PRINCIPAL INVESTIGATOR

• Mike Kagawa, MMed

  Makerere University

  STUDY DIRECTOR

• Anthony Okoth, MMed

  Mulago National Referral Hospital

  STUDY DIRECTOR

• Joseph Kigula-Mugambe, MMed

  Mulago National Referral Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2013
• First Posted: September 9, 2013
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: September 9, 2013

Record last verified: 2013-09