About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Curcumin
- Palliative radiotherapy
Treatment groups
Sponsors and collaborators
Addis Ababa University
Lead sponsor
Akay Natural Ingredients Private Limited
Collaborator