Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial

NCT ID: NCT05947513

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2026-04-30

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Concurrent Curcumin Palliative Radiotherapy

Daily 1000 mg oral CGM Curcumin in four divided doses for seven days prior to the start of and for three to five weeks concurrently with palliative radiotherapy.

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

Curcumin formulation with enhanced bioavailability which contains food-grade curcumin 35% (w/w) combined with the galactomannan fiber from fenugreek seeds.

Palliative radiotherapy

Intervention Type: RADIATION

As per the treatment guidelines of the Tikur Anbessa Hospital Radiotherapy Center, standard-of-care palliative or non-radical radiotherapy entails treatment of advanced cervical cancer patients at a biologically effective dose of 45-55 Gy over the course of three to five weeks.

Interventions

Curcumin

Curcumin formulation with enhanced bioavailability which contains food-grade curcumin 35% (w/w) combined with the galactomannan fiber from fenugreek seeds.

Intervention Type: DRUG

Palliative radiotherapy

As per the treatment guidelines of the Tikur Anbessa Hospital Radiotherapy Center, standard-of-care palliative or non-radical radiotherapy entails treatment of advanced cervical cancer patients at a biologically effective dose of 45-55 Gy over the course of three to five weeks.

Intervention Type: RADIATION

Other Intervention Names

Curcumagalactomannoside (CGM); CurQfen; Non-radical radiotherapy

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Akay Natural Ingredients Private Limited

UNKNOWN

Sponsor Role: collaborator

Addis Ababa University

OTHER

Sponsor Role: lead

Responsible Party

Biniyam Girma

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eyasu Makonnen, Bpharm, PhD

Role: STUDY_CHAIR

Addis Ababa University

Biniyam Girma, Bpharm, MSc

Role: STUDY_DIRECTOR

Addis Ababa University

Wondemagegnehu Tigeneh, MD, MMed(RT)

Role: PRINCIPAL_INVESTIGATOR

Addis Ababa University

Locations

Tikur Anbessa Specialized Hospital

Addis Ababa, , Ethiopia

Site Status: RECRUITING

Countries

Ethiopia

Central Contacts

Biniyam Girma, Bpharm, MSc

Role: CONTACT

biniyam.girma@ju.edu.et

093-708-9518 ext. 251

Michele Joseph, MSc, MPH

Role: CONTACT

michele.joseph@aau.edu.et

092-914-2593 ext. 251

Facility Contacts

Wondemagegnehu Tignehe, MD

Role: primary

tigeneh@yahoo.com

Other Identifiers

001/21/SoP

Identifier Type: -

Identifier Source: org_study_id