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

NCT05947513 NA RECRUITING

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.

Details

Lead sponsor	Addis Ababa University
Phase	NA
Status	RECRUITING
Enrolment	27
Start date	2025-04-10
Completion	2026-04

Conditions

• Cervical Cancer

Interventions

• Curcumin
• Palliative radiotherapy

Primary outcomes

• Treatment Fidelity Rate — From initiation (Day 1) up to end of treatment over 4-6 weeks
  Proportion of participants who received the study treatment as planned
• Objective Response Rate (ORR) — Time Frame: 13-17 weeks
  Objective Response Rate is defined as proportion of participants having a complete response (CR) or partial response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Countries

Ethiopia