Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial
- Conditions
- Cervical Cancer
- Interventions
- Radiation: Palliative radiotherapy
- Registration Number
- NCT05947513
- Lead Sponsor
- Addis Ababa University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Concurrent Curcumin Palliative Radiotherapy Curcumin 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. Concurrent Curcumin Palliative Radiotherapy Palliative radiotherapy 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.
- Primary Outcome Measures
Name Time Method Treatment Fidelity Rate From initiation (Day 1) up to end of treatment over 4-6 weeks Proportion of participants who received the study treatment as planned
Objective Response Rate (ORR) Time Frame: 13-17 weeks 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.
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0 Up to 10-14 weeks from treatment initiation 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
Incidence of Dose Reduction in curcumin and radiotherapy regimens : From initiation (Day 1) up to end treatment over 4-6 weeks 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
Incidence of Dose Interruption in curcumin and radiotherapy regimens From initiation (Day 1) up to end treatment over 4-6 weeks 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
Relative Dose Intensity (RDI) of curcumin and radiotherapy From initiation (Day 1) up to end treatment over 4-6 weeks Relative dose intensity is defined as dose intensity (actual DI) divided by the protocol weekly dose (planned DI), expressed as a percentage.
Dose Intensity (DI) of curcumin and radiotherapy From initiation (Day 1) up to end treatment over 4-6 weeks Dose intensity is defined as cumulative dose divided by the treatment duration in weeks
Disease Control Rate (DCR) 13-17 weeks 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.
Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-C30 at 7-9 weeks Baseline, 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.
Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-CX24 at 13-17 weeks Baseline, 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.
Peak Plasma Concentration (Cmax) of CGM Curcumin 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 Peak Plasma Concentration represents the highest observed curcumin concentration observed in plasma over all PK sample concentrations following single-dose CGM Curcumin administration.
Time to Peak Plasma Concentration (Tmax) of CGM Curcumin 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 Time to Peak Plasma Concentration (Tmax) represents the time when Cmax of curcumin occurs following single-dose CGM Curcumin administration.
Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-C30 at 13-17 weeks Baseline, 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.
Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-CX24 at 7-9 weeks Baseline, 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.
Area under the Plasma Concentration versus Time Curve (AUCτ) of CGM Curcumin 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 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.
Half-life (T1/2) of CGM Curcumin 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 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.
Assessment Completion Rate through study completion, an average of 1 year Assessment Completion Rate is defined as the proportion of assessments that could be completed as planned.
Attrition Rate through study completion, an average of 1 year Attrition Rate is defined as the proportion of participants who withdraw from the study.
Recruitment Rate through study completion, an average of 1 year Recruitment Rate is defined as the proportion of those who participate in the trial who were approached as potential participants.
Trial Locations
- Locations (1)
Tikur Anbessa Specialized Hospital
🇪🇹Addis Ababa, Ethiopia