AzTrials
AzTrials

Cervical CancerCuPRACNCT05947513

Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial

A study testing Curcumin and Palliative radiotherapy in people with Cervical Cancer, run by Addis Ababa University at 1 site in Ethiopia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Curcumin and Palliative radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteEthiopia
Study dates
10 Apr 2025to Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Biniyam Girma, Bpharm, MSc contact

093-708-9518 ext. 251

biniyam.girma@ju.edu.et

Michele Joseph, MSc, MPH contact

092-914-2593 ext. 251

michele.joseph@aau.edu.et

Ethiopia1 site, 1 recruiting
  • Tikur Anbessa Specialized Hospital

    Addis Ababa

    Wondemagegnehu Tignehe, MD, tigeneh@yahoo.com

    Recruiting

Other trials in Ethiopia

About this study

Official title: Feasibility, Safety, and Efficacy of Concomitant Curcumin in Patients Undergoing Palliative Radiotherapy for FIGO Stage IIIB-IVA Cervical Cancer: An Open-label Pilot 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?
Read more

Participants will:

  1. 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
Cervical Cancer
Being tested
Curcumin, Palliative radiotherapy
Keywords
Curcumin, Cervical cancer, Radiosensitizer
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CurcuminDrug

    Also called Curcumagalactomannoside (CGM), CurQfen

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

  • Palliative radiotherapyRadiation

    Also called Non-radical radiotherapy

    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.

Study groups in NCT05947513
Study groupRoleWhat they receive
Concurrent Curcumin Palliative RadiotherapyExperimentalDaily 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.
Receives: Drug: Curcumin; Radiation: Palliative radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment Fidelity Rate

    Proportion of participants who received the study treatment as planned

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

  2. 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.

    Measured: Time Frame: 13-17 weeks

Secondary outcomes (17)
  1. Incidence of Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0

    Any new or worsening of a pre-existing untoward sign, symptom, or disease, including a clinically significant laboratory or vital sign abnormality during study treatment, is defined as a treatment emergent adverse event

    Measured: Up to 10-14 weeks from treatment initiation

  2. Incidence of Dose Reduction in curcumin and radiotherapy regimens

    Incidence of Dose A dose reduction is a decrease in dose from the protocol planned starting dose or a decrease from the previous non-zero dose, even if this decrease has been directly preceded by an interruption in curcumin and radiotherapy regimens

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

  3. Incidence of Dose Interruption in curcumin and radiotherapy regimens

    A Dose Interruption is defined a zero dose given on one or more days on which the protocol-specified dose is non-zero, followed by resumption of dosing

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

  4. Dose Intensity (DI) of curcumin and radiotherapy

    Dose intensity is defined as cumulative dose divided by the treatment duration in weeks

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

  5. Relative Dose Intensity (RDI) of curcumin and radiotherapy

    Relative dose intensity is defined as dose intensity (actual DI) divided by the protocol weekly dose (planned DI), expressed as a percentage.

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

  6. Disease Control Rate (DCR)

    Disease control rate (DCR): proportion of participants having a complete response (CR) or partial response (PR) or stable disease (SD) as defined by the RECIST 1.1 criteria.

    Measured: 13-17 weeks

  7. Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-C30 at 7-9 weeks

    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) measures quality of life in cancer patients by evaluating physical, psychological, and social functions. Possible scores range from zero to 100, with a higher scale score indicating a higher response level. As such, high scores on functional and global health status (QoL) scales indicate healthy levels of functioning and high quality of life, respectively. However, a high score on the symptoms scale or item indicates more problems or symptomatology.

    Measured: Baseline, 7-9 weeks

  8. Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-C30 at 13-17 weeks

    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) measures quality of life in cancer patients by evaluating physical, psychological, and social functions. Possible scores range from zero to 100, with a higher scale score indicating a higher response level. As such, high scores on functional and global health status (QoL) scales indicate healthy levels of functioning and high quality of life, respectively. However, a high score on the symptoms scale or item indicates more problems or symptomatology.

    Measured: Baseline, 13-17 weeks

  9. Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-CX24 at 7-9 weeks

    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module (EORTC QLQ-CX24) measures quality of life in cervical cancer patients in combination with the QLQ-C30. Possible scores range from zero to 100 for all scale and single-item measures. While a high score on the functional single-items indicates a high degree of functioning, a high score on the symptom scales or single-items indicates a high level of symptomatology or difficulties.

    Measured: Baseline, 7-9 weeks

  10. Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-CX24 at 13-17 weeks

    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module (EORTC QLQ-CX24) measures quality of life in cervical cancer patients in combination with the QLQ-C30. Possible scores range from zero to 100 for all scale and single-item measures. While a high score on the functional single-items indicates a high degree of functioning, a high score on the symptom scales or single-items indicates a high level of symptomatology or difficulties.

    Measured: Baseline, 13-17 weeks

  11. Peak Plasma Concentration (Cmax) of CGM Curcumin

    Peak Plasma Concentration represents the highest observed curcumin concentration observed in plasma over all PK sample concentrations following single-dose CGM Curcumin administration.

    Measured: Day 1: pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours and 6 hours post-dose; Day 6: 30 minutes before the next daily dose, and 1 hour post- dose

  12. Time to Peak Plasma Concentration (Tmax) of CGM Curcumin

    Time to Peak Plasma Concentration (Tmax) represents the time when Cmax of curcumin occurs following single-dose CGM Curcumin administration.

    Measured: Day 1: pre-dose, 30 minutes, 1 hour, 1.5 hours, 2hours, 4 hours and 6 hours post-dose; Day 6: 30 minutes before the next daily dose, and 1 hour post- dose

  13. Area under the Plasma Concentration versus Time Curve (AUCτ) of CGM Curcumin

    Area under the Plasma Concentration versus Time Curve (AUCτ) represents the area under the concentration-time curve of curcumin from time zero to the time of the end of dosing interval following single-dose CGM Curcumin administration.

    Measured: Day 1: pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours and 6 hours post-dose; Day 6: 30 minutes before the next daily dose, and 1 hour post- dose

  14. Half-life (T1/2) of CGM Curcumin

    Half-life (T1/2) represents the time for plasma concentration of curcumin to fall by a factor of one-half in the terminal phase following single-dose CGM Curcumin administration.

    Measured: Day 1: pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours and 6 hours post-dose; Day 6: 30 minutes before the next daily dose, and 1 hour post- dose

  15. Recruitment Rate

    Recruitment Rate is defined as the proportion of those who participate in the trial who were approached as potential participants.

    Measured: through study completion, an average of 1 year

  16. Assessment Completion Rate

    Assessment Completion Rate is defined as the proportion of assessments that could be completed as planned.

    Measured: through study completion, an average of 1 year

  17. Attrition Rate

    Attrition Rate is defined as the proportion of participants who withdraw from the study.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2023
  2. Study start10 Apr 2025
  3. Primary completionFeb 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05947513
Sponsor's protocol ID
001/21/SoP
Acronym
CuPRAC
Status last verified
Apr 2025
First submitted
21 Jun 2023
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Curcumin and Palliative radiotherapy in people with Cervical Cancer, run by Addis Ababa University at 1 site in Ethiopia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Biniyam Girma, Bpharm, MSc (093-708-9518 ext. 251, biniyam.girma@ju.edu.et), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Fidelity Rate (time frame: From initiation (Day 1) up to end of treatment over 4-6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in