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Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial

ConditionCervical Cancer
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Curcumin

    Drug

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

  • 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.

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Concurrent Curcumin Palliative RadiotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Treatment Fidelity Rate

Proportion of participants who received the study treatment as planned

Time frame
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.

Time frame
Time Frame: 13-17 weeks

Secondary outcomes

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

Time frame
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

Time frame
: 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

Time frame
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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Addis Ababa University

Lead sponsor

Akay Natural Ingredients Private Limited

Collaborator

Source ClinicalTrials.gov
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