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| Name | Class |
|---|---|
| Akay Natural Ingredients Private Limited | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin | Drug | Curcumin formulation with enhanced bioavailability which contains food-grade curcumin 35% (w/w) combined with the galactomannan fiber from fenugreek seeds. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 10-14 weeks from treatment initiation |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biniyam Girma, Bpharm, MSc | Contact | 093-708-9518 | 251 | biniyam.girma@ju.edu.et |
| Michele Joseph, MSc, MPH | Contact | 092-914-2593 | 251 | michele.joseph@aau.edu.et |
| Name | Affiliation | Role |
|---|---|---|
| Eyasu Makonnen, Bpharm, PhD | Addis Ababa University | Study Chair |
| Biniyam Girma, Bpharm, MSc | Addis Ababa University | Study Director |
| Wondemagegnehu Tigeneh, MD, MMed(RT) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tikur Anbessa Specialized Hospital | Recruiting | Addis Ababa | Ethiopia |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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|
| 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. |
|
|
| 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 | : From initiation (Day 1) up to end treatment over 4-6 weeks |
| 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 | From initiation (Day 1) up to end treatment over 4-6 weeks |
| Dose Intensity (DI) of curcumin and radiotherapy | Dose intensity is defined as cumulative dose divided by the treatment duration in weeks | From initiation (Day 1) up to end treatment over 4-6 weeks |
| 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. | From initiation (Day 1) up to end treatment over 4-6 weeks |
| 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. | 13-17 weeks |
| 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. | Baseline, 7-9 weeks |
| 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. | Baseline, 13-17 weeks |
| 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. | Baseline, 7-9 weeks |
| 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. | Baseline, 13-17 weeks |
| 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. | 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 |
| 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. | 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 |
| 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. | 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) 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. | 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 |
| Recruitment Rate | Recruitment Rate is defined as the proportion of those who participate in the trial who were approached as potential participants. | through study completion, an average of 1 year |
| Assessment Completion Rate | Assessment Completion Rate is defined as the proportion of assessments that could be completed as planned. | through study completion, an average of 1 year |
| Attrition Rate | Attrition Rate is defined as the proportion of participants who withdraw from the study. | through study completion, an average of 1 year |
| Addis Ababa University |
| Principal Investigator |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |