Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial

Last updated: April 16, 2025
Sponsor: Addis Ababa University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cervical Cancer

Pelvic Cancer

Dysfunctional Uterine Bleeding

Treatment

Palliative radiotherapy

Curcumin

Clinical Study ID

NCT05947513
001/21/SoP
  • Ages > 18
  • Female

Study 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

Inclusion criteria:

  • Age >18 years old (Adult, Older Adult)

  • Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamouscarcinoma of the cervix, FIGO stage IIIB-IVA

  • Undergoing for standard of care palliative radiotherapy without chemotherapy as perthe local treatment guideline

  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2

  • Adequate liver function (aspartate aminotransferase (AST) and alanineaminotransferase (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; plateletcount ≥100.000/mm3; hemoglobin ≥10.0 g/dL); renal function (serum creatinine ≤1.5 xULN; estimate creatinine clearance (Cockcroft-Gault) ≥60 mL/min)

  • Participants must have measureable disease according to the Response EvaluationCriteria in Solid Tumors (RECIST) V1.1.

  • Agree to use an effective form of contraception (e.g., true abstinence (not periodicabstinence), barrier contraception, highly effective hormonal contraception) if theparticipant is of child bearing age

  • Give informed consent

Exclusion

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 weeksbefore enrollment

  • Received any previous radiation or chemotherapy for cervical cancer

  • Underwent surgery in the four weeks prior to the enrolment date or scheduled toundergo surgery within eight weeks after end of treatment

  • Currently using of any chemotherapy or scheduled to receive within eight weeks afterend 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 trialintervention and/or prohibit adequate compliance to study requirements includingchronic ongoing infections (like HIV, Hepatitis B or C), uncontrolled hypertension,heart failure, cardiac arrhythmia, unstable angina, chronic obstructive lungdisease, diabetes mellitus, chronic renal disease, chronic liver disease, biliarytract obstruction or cholelithiasis, gastric or duodenal ulcers, autoimmune orinflammatory disorders, a coagulation or platelet disorder, seizure disorders andpsychiatric illness. Patients with disorders other than the ones specified above mayalso 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 orrequired follow-up. For instance, if travel to and from treatment site is an issue.

Study Design

Total Participants: 27
Treatment Group(s): 2
Primary Treatment: Palliative radiotherapy
Phase:
Study Start date:
April 10, 2025
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Tikur Anbessa Specialized Hospital

    Addis Ababa,
    Ethiopia

    Active - Recruiting

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