Using curcumin with palliative radiotherapy for advanced cervical cancer
Feasibility, Safety, and Efficacy of Concomitant Curcumin in Patients Undergoing Palliative Radiotherapy for FIGO Stage IIIB-IVA Cervical Cancer: An Open-label Pilot Trial
This study is testing if adding curcumin to regular radiation treatment can help people with advanced cervical cancer feel better and improve their treatment results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Addis Ababa University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Addis Ababa) |
| Trial ID | NCT05947513 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility, safety, and therapeutic response of adding curcumin to standard palliative radiotherapy in patients with advanced cervical cancer. Participants will take curcumin capsules alongside their prescribed radiation treatment for 4-6 weeks and will undergo various assessments, including blood and urine tests to measure curcumin levels and CT scans to evaluate tumor response. The study seeks to determine if curcumin can enhance the effectiveness of radiation therapy in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically confirmed advanced cervical cancer who are receiving palliative radiotherapy.
Not a fit: Patients with early-stage cervical cancer or those receiving chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced cervical cancer undergoing palliative care.
How similar studies have performed: While the use of curcumin as an adjunct treatment is being explored, this specific combination with palliative radiotherapy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Addis Ababa
- Tikur Anbessa Specialized Hospital — Addis Ababa, Ethiopia (Recruiting)
Study contacts
- Principal investigator: Wondemagegnehu Tigeneh, MD, MMed(RT) — Addis Ababa University
- Study coordinator: Biniyam Girma, Bpharm, MSc
- Email: biniyam.girma@ju.edu.et
- Phone: 093-708-9518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.