NCT05947513 Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial
| NCT ID | NCT05947513 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Addis Ababa University |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 27 participants in total. It began in 2025-04-10 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion criteria: * Age \>18 years old (Adult, Older Adult) * Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IIIB-IVA * Undergoing for standard of care palliative radiotherapy without chemotherapy as per the local treatment guideline * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2 * Adequate liver function (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (Upper Limit of Normal); total serum bilirubin ≤1.5 x ULN); blood cell counts (absolute neutrophils count ≥1.500/mm3; platelet count ≥100.000/mm3; hemoglobin ≥10.0 g/dL); renal function (serum creatinine ≤1.5 x ULN; estimate creatinine clearance (Cockcroft-Gault) ≥60 mL/min) * Participants must have measureable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1. * Agree to use an effective form of contraception (e.g., true abstinence (not periodic abstinence), barrier contraception, highly effective hormonal contraception) if the participant is of child bearing age * Give informed consent Exclusion criteria: * Cervical cancer patients who are candidates for single dose palliative radiotherapy * Patients with severe or bilateral hydronephrosis * Evidence of distant metastases * Receiving any other investigational agent concurrently or within the last 4 weeks before enrollment * Received any previous radiation or chemotherapy for cervical cancer * Underwent surgery in the four weeks prior to the enrolment date or scheduled to undergo surgery within eight weeks after end of treatment * Currently using of any chemotherapy or scheduled to receive within eight weeks after end of treatment * Known allergy to turmeric or its derivatives (ginger, curry, cumin, or cardamom) * Known allergy to fenugreek, peanut, soy, lentil, pea, bean, and chickpea * Presence of conditions that precludes the safe administration of the trial intervention and/or prohibit adequate compliance to study requirements including chronic ongoing infections (like HIV, Hepatitis B or C), uncontrolled hypertension, heart failure, cardiac arrhythmia, unstable angina, chronic obstructive lung disease, diabetes mellitus, chronic renal disease, chronic liver disease, biliary tract obstruction or cholelithiasis, gastric or duodenal ulcers, autoimmune or inflammatory disorders, a coagulation or platelet disorder, seizure disorders and psychiatric illness. Patients with disorders other than the ones specified above may also be excluded based on the judgment of the principal investigator. * Pregnant and breastfeeding women * Participants with circumstances that will not permit completion of the study or required follow-up. For instance, if travel to and from treatment site is an issue.
Contact & Investigator
Eyasu Makonnen, Bpharm, PhD
STUDY CHAIR
Addis Ababa University
Frequently Asked Questions
Who can join the NCT05947513 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05947513 currently recruiting?
Yes, NCT05947513 is actively recruiting participants. Contact the research team at biniyam.girma@ju.edu.et for enrollment information.
Where is the NCT05947513 trial being conducted?
This trial is being conducted at Addis Ababa, Ethiopia.
Who is sponsoring the NCT05947513 clinical trial?
NCT05947513 is sponsored by Addis Ababa University. The principal investigator is Eyasu Makonnen, Bpharm, PhD at Addis Ababa University. The trial plans to enroll 27 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.