Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05947513

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Tikur Anbessa Specialized Hospital

Addis Ababa, Ethiopia

Actively Recruiting

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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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