Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial

Trial Title: Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial

NCT ID: NCT05947513

Condition: Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms
Curcumin

Conditions: Keywords:
Curcumin
Cervical cancer
Radiosensitizer

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Curcumin
Description: Curcumin formulation with enhanced bioavailability which contains food-grade curcumin 35% (w/w) combined with the galactomannan fiber from fenugreek seeds.
Arm group label: Concurrent Curcumin Palliative Radiotherapy

Other name: Curcumagalactomannoside (CGM)

Other name: CurQfen

Intervention type: Radiation
Intervention name: Palliative radiotherapy
Description: 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.
Arm group label: Concurrent Curcumin Palliative Radiotherapy

Other name: Non-radical radiotherapy

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: - Is adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients safe? - Does adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients improve therapeutic responses? - How much curcumin is absorbed into the body and how long will it stay in the body? Participants will: - Take two 500 mg curcumin capsules twice per day for 4-6 weeks in addition to the prescribed palliative radiotherapy. - Provide blood and urine samples for laboratory tests. - Provide blood samples to measure curcumin levels in their body. - Obtain CT-scan to measure their tumor response. - Complete questioners to measure improvements to their quality of life, if any.

Criteria for 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 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.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: October 2023

Completion date: November 2024

Lead sponsor:
Agency: Addis Ababa University
Agency class: Other

Collaborator:
Agency: Center for Innovative Drug Development and Therapeutic Trials for Africa, Addis Ababa University
Agency class: Other

Collaborator:
Agency: Akay Natural Ingredients Private Limited
Agency class: Other

Source: Addis Ababa University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05947513