Actively Recruiting
Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial
Led by Addis Ababa University · Updated on 2025-04-20
27
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
Sponsors
A
Addis Ababa University
Lead Sponsor
A
Akay Natural Ingredients Private Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years old
- Confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix at FIGO stage IIIB-IVA
- Receiving standard palliative radiotherapy without chemotherapy as per local guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Adequate liver, blood, and kidney function based on specified laboratory values
- Measurable disease according to RECIST V1.1 criteria
- Agreement to use effective contraception if of childbearing age
- Ability to provide informed consent
You will not qualify if you...
- Candidates for single dose palliative radiotherapy
- Severe or bilateral hydronephrosis
- Evidence of distant metastases
- Use of other investigational agents within 4 weeks before enrollment
- Prior radiation or chemotherapy for cervical cancer
- Surgery within 4 weeks before enrollment or planned surgery within 8 weeks after treatment
- Current or planned chemotherapy within 8 weeks after treatment
- Known allergies to turmeric, fenugreek, peanuts, soy, lentils, peas, beans, or chickpeas
- Conditions preventing safe study participation or compliance, including chronic infections (HIV, Hepatitis B or C), uncontrolled hypertension, heart failure, cardiac arrhythmia, unstable angina, chronic lung disease, diabetes, chronic kidney or liver disease, biliary obstruction, ulcers, autoimmune or inflammatory disorders, coagulation or platelet disorders, seizure disorders, psychiatric illness
- Pregnancy or breastfeeding
- Inability to complete the study or attend required follow-up visits, such as due to travel difficulties
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tikur Anbessa Specialized Hospital
Addis Ababa, Ethiopia
Actively Recruiting
Research Team
B
Biniyam Girma, Bpharm, MSc
CONTACT
M
Michele Joseph, MSc, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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