Feasibility, Safety, and Efficacy of Concomitant Curcumin in Patients Undergoing Palliative Radiotherapy for FIGO Stage IIIB-IVA Cervical Cancer: An Open-label Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Treatment Fidelity Rate
研究概览
简要总结
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:
- Is adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients feasible? Is conducting this study feasible?
- Does adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients improve therapeutic responses?
- Is adding curcumin to standard-of-care palliative radiotherapy of cervical cancer patients safe?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Concurrent Curcumin 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.
干预措施: Curcumin (Drug)
Concurrent Curcumin 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.
干预措施: Palliative radiotherapy (Radiation)
结局指标
主要结局
Treatment Fidelity Rate
时间窗: 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)
时间窗: 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.
次要结局
- Incidence of Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0(Up to 10-14 weeks from treatment initiation)
- Incidence of Dose Reduction 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(From initiation (Day 1) up to end treatment over 4-6 weeks)
- Relative Dose Intensity (RDI) of curcumin and radiotherapy(From initiation (Day 1) up to end treatment over 4-6 weeks)
- Dose Intensity (DI) of curcumin and radiotherapy(From initiation (Day 1) up to end treatment over 4-6 weeks)
- Disease Control Rate (DCR)(13-17 weeks)
- Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-C30 at 7-9 weeks(Baseline, 7-9 weeks)
- Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-CX24 at 13-17 weeks(Baseline, 13-17 weeks)
- 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)
- 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)
- Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-C30 at 13-17 weeks(Baseline, 13-17 weeks)
- Change from baseline in Health-Related Quality of Life (QOL) as assessed using EORTC QLQ-CX24 at 7-9 weeks(Baseline, 7-9 weeks)
- 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)
- 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)
- Assessment Completion Rate(through study completion, an average of 1 year)
- Attrition Rate(through study completion, an average of 1 year)
- Recruitment Rate(through study completion, an average of 1 year)
研究者
Biniyam Girma
Principal Investigator
Addis Ababa University