Clinical trial NCT05947513: Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: Curcumin
Cervical cancer
Radiosensitizer
Lead sponsor: Addis Ababa University
Sponsor class: OTHER
Collaborators: name: Akay Natural Ingredients Private Limited
First posted: 2023-07-17
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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: Inclusion criteria:

* 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

Exclusion criteria:

* 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.

Primary outcomes:
measure: Treatment Fidelity Rate
timeFrame: From initiation (Day 1) up to end of treatment over 4-6 weeks
measure: Objective Response Rate (ORR)
timeFrame: Time Frame: 13-17 weeks
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
timeFrame: Up to 10-14 weeks from treatment initiation
measure: Incidence of Dose Reduction in curcumin and radiotherapy regimens
timeFrame: : From initiation (Day 1) up to end treatment over 4-6 weeks
measure: Incidence of Dose Interruption in curcumin and radiotherapy regimens
timeFrame: From initiation (Day 1) up to end treatment over 4-6 weeks
measure: Dose Intensity (DI) of curcumin and radiotherapy
timeFrame: From initiation (Day 1) up to end treatment over 4-6 weeks
measure: Relative Dose Intensity (RDI) of curcumin and radiotherapy
timeFrame: From initiation (Day 1) up to end treatment over 4-6 weeks
measure: Disease Control Rate (DCR)
timeFrame: 13-17 weeks
measure: Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-C30 at 7-9 weeks
timeFrame: Baseline, 7-9 weeks
measure: Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-C30 at 13-17 weeks
timeFrame: Baseline, 13-17 weeks
measure: Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-CX24 at 7-9 weeks
timeFrame: Baseline, 7-9 weeks
measure: Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-CX24 at 13-17 weeks
timeFrame: Baseline, 13-17 weeks
measure: Peak Plasma Concentration (Cmax) of CGM Curcumin
timeFrame: 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
measure: Time to Peak Plasma Concentration (Tmax) of CGM Curcumin
timeFrame: 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
measure: Area under the Plasma Concentration versus Time Curve (AUCτ) of CGM Curcumin
timeFrame: 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
measure: Half-life (T1/2) of CGM Curcumin
timeFrame: 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
measure: Recruitment Rate
timeFrame: through study completion, an average of 1 year
measure: Assessment Completion Rate
timeFrame: through study completion, an average of 1 year
measure: Attrition Rate
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Tikur Anbessa Specialized Hospital
Study officials:
affiliation: Addis Ababa University
name: Eyasu Makonnen, Bpharm, PhD
role: STUDY_CHAIR
affiliation: Addis Ababa University
name: Biniyam Girma, Bpharm, MSc
role: STUDY_DIRECTOR
affiliation: Addis Ababa University
name: Wondemagegnehu Tigeneh, MD, MMed(RT)
role: PRINCIPAL_INVESTIGATOR
References: