Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial

NCT05947513 | Recruiting DMC

• 1 other identifier: 001/21/SoP
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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:

1. 1.Is adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients feasible? Is conducting this study feasible?
2. 2.Does adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients improve therapeutic responses?
3. 3.Is adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients safe?
4. 4.How much curcumin is absorbed into the body and how long will it stay in the body?

Conditions

Cervical Cancer

Keywords

Curcumin; Cervical cancer; Radiosensitizer

Outcome Measures

Primary Outcomes (2)

• Treatment Fidelity Rate

  Proportion of participants who received the study treatment as planned

  From initiation (Day 1) up to end of treatment over 4-6 weeks

• Objective Response Rate (ORR)

  Objective Response Rate is defined as proportion of participants having a complete response (CR) or partial response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  Time Frame: 13-17 weeks

Secondary Outcomes (17)

• Incidence of Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0

  Up to 10-14 weeks from treatment initiation

• Incidence of Dose Reduction in curcumin and radiotherapy regimens

  : From initiation (Day 1) up to end treatment over 4-6 weeks

• Incidence of Dose Interruption in curcumin and radiotherapy regimens

  From initiation (Day 1) up to end treatment over 4-6 weeks

• Dose Intensity (DI) of curcumin and radiotherapy

  From initiation (Day 1) up to end treatment over 4-6 weeks

• Relative Dose Intensity (RDI) of curcumin and radiotherapy

  From initiation (Day 1) up to end treatment over 4-6 weeks

Study Arms (1)

Concurrent Curcumin Palliative Radiotherapy

EXPERIMENTAL

Daily 1000 mg oral CGM Curcumin in four divided doses for seven days prior to the start of and for three to five weeks concurrently with palliative radiotherapy.

Drug: Curcumin; Radiation: Palliative radiotherapy

Interventions

Curcumin DRUG

Curcumin formulation with enhanced bioavailability which contains food-grade curcumin 35% (w/w) combined with the galactomannan fiber from fenugreek seeds.

Also known as: Curcumagalactomannoside (CGM), CurQfen

Concurrent Curcumin Palliative Radiotherapy

Palliative radiotherapy RADIATION

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.

Also known as: Non-radical radiotherapy

Concurrent Curcumin Palliative Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Addis Ababa University: lead
• Akay Natural Ingredients Private Limited: collaborator

Study Sites (1)

Tikur Anbessa Specialized Hospital

Addis Ababa, Ethiopia

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Eyasu Makonnen, Bpharm, PhD

  Addis Ababa University

  STUDY CHAIR

• Biniyam Girma, Bpharm, MSc

  Addis Ababa University

  STUDY DIRECTOR

• Wondemagegnehu Tigeneh, MD, MMed(RT)

  Addis Ababa University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Biniyam Girma, Bpharm, MSc

CONTACT

093-708-9518; biniyam.girma@ju.edu.et

Michele Joseph, MSc, MPH

CONTACT

092-914-2593; michele.joseph@aau.edu.et

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 17, 2023
• Study Start: April 10, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)