RecruitingNot ApplicableNCT05947513

Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial

Feasibility, Safety, and Efficacy of Concomitant Curcumin in Patients Undergoing Palliative Radiotherapy for FIGO Stage IIIB-IVA Cervical Cancer: An Open-label Pilot Trial

Sponsor

Addis Ababa University

Enrollment

27 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding curcumin (a natural compound found in turmeric) to palliative radiation therapy can improve outcomes for women with advanced cervical cancer. Curcumin may help make cancer cells more sensitive to radiation and reduce inflammation. **You may be eligible if...** - You are over 18 and have advanced cervical cancer (Stage IIIB–IVA) confirmed by biopsy - You are scheduled for palliative radiation therapy without chemotherapy - Your overall health is adequate (ECOG performance status 0–2) - Your blood counts and organ function meet the study's requirements - You have not had prior radiation or chemotherapy for cervical cancer **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have a severe kidney blockage on both sides - You have allergies to turmeric, ginger, curry, cumin, cardamom, fenugreek, peanuts, soy, lentils, or legumes - You have serious chronic conditions like uncontrolled hypertension, diabetes, heart failure, or HIV - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCurcumin

Curcumin formulation with enhanced bioavailability which contains food-grade curcumin 35% (w/w) combined with the galactomannan fiber from fenugreek seeds.

RADIATIONPalliative 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.