Using curcumin with palliative radiotherapy for advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.