NCT05947513Recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- First submitted
- 21 Jun 2023
- Start date
- 10 Apr 2025
- Primary completion date
- Feb 2026
- Lead sponsor
- Addis Ababa University
- Diseases
- Cervical cancer
- NCT number
- NCT05947513
What you commit to
- Study type: Interventional
- Planned participants: 27
- From 10 Apr 2025 to the primary completion date, Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Cervical cancer patients who are candidates for single dose palliative radiotherapy
- Known allergy to turmeric or its derivatives (ginger, curry, cumin, or cardamom)
- Known allergy to fenugreek, peanut, soy, lentil, pea, bean, and chickpea
Lab values
- 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.
Other
- Patients with severe or bilateral hydronephrosis
- Evidence of distant metastases
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tikur Anbessa Specialized Hospital Coordinator of this site? Confirm its status | Addis Ababa | Ethiopia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.