Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial
NCT05947513 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2025-04-20
Summary
The goal of this clinical trial is to test curcumin as an adjunct treatment in patients with cervical cancer receiving standard-of-care palliative radiation. The main questions it aims to answer are:
1. Is adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients feasible? Is conducting this study feasible?
2. Does adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients improve therapeutic responses?
3. Is adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients safe?
4. How much curcumin is absorbed into the body and how long will it stay in the body?
Participants will:
i. Take 250 mg curcumin capsules four times per day for 4-6 weeks in addition to the prescribed palliative radiotherapy.
ii. Provide blood and urine samples for laboratory tests. iii. Provide blood samples to measure curcumin levels in their body. iv. Obtain CT-scan to measure their tumor response. v. Complete questioners to measure improvements to their quality of life, if any.
Conditions
Interventions
- DRUG
-
Curcumin
Curcumin formulation with enhanced bioavailability which contains food-grade curcumin 35% (w/w) combined with the galactomannan fiber from fenugreek seeds.
- RADIATION
-
Palliative radiotherapy
As per the treatment guidelines of the Tikur Anbessa Hospital Radiotherapy Center, standard-of-care palliative or non-radical radiotherapy entails treatment of advanced cervical cancer patients at a biologically effective dose of 45-55 Gy over the course of three to five weeks.
Sponsors & Collaborators
-
Akay Natural Ingredients Private Limited
collaborator UNKNOWN -
Addis Ababa University
lead OTHER
Principal Investigators
-
Eyasu Makonnen, Bpharm, PhD · Addis Ababa University
-
Biniyam Girma, Bpharm, MSc · Addis Ababa University
-
Wondemagegnehu Tigeneh, MD, MMed(RT) · Addis Ababa University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-10
- Primary Completion
- 2026-02-28
- Completion
- 2026-04-30
Countries
- Ethiopia
Study Locations
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