Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAddis Ababa University

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

27 Participants
are divided into 1 treatment group

Sponsors and collaborators

Addis Ababa University

Lead sponsor

Akay Natural Ingredients Private Limited

Collaborator