Does Timing Matter? A Trial of Time Restricted Eating in Haematological Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Epigenetic Analysis via PBMC Profiling
研究概览
简要总结
The goal of this clinical trial is to learn if time restricted eating (TRE), a form of intermittent fasting, can impact health outcomes in patients with chronic lymphocytic leukemia (CLL). The main questions it aims to answer are:
- In patients with CLL, is there a decrease or stabilization in cancer cell counts associated with TRE compared to baseline?
- Is there a decrease in immune cell autophagy (a cellular recycling process) activity associated with TRE compared to baseline?
- Does adherence to a TRE regimen improve patient experience and quality of life?
Immune cell autophagy activity in cancer patients will be compared to a subset of control participants without cancer.
Participants will:
- Adhere to a 16/8 fasting regimen, which involves eating as normal for 8 hours per day and fasting (only consuming water, black coffee or black tea) for the remaining 16 hours. They will follow this intervention for their choice of either 3 or 6 months.
- Complete monthly blood collections
- Complete weekly journal entries to record weekly weight and timing of first and last daily meals
- Complete weekly safety check-ins with a study team member for the first 4 weeks of the study and then bi-weekly thereafter
- Complete 3 quality of life questionnaires
- Provide 3 stool samples (optional component of study)
- Complete an end of study interview (optional component of study)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Experimental Participants:
- •Diagnosis of CLL or SLL, Age 18-85
- •Peripheral blood lymphocytes >20 x 10^9/L
- •Hemoglobin >90g/L
- •Platelets ˃90 x 10^9/L
- •BMI of >=20kg/m2
- •ECOG Performance Status >=2
- •Not following any form of IF for 4 months prior to study
- •Control Participants:
- •Absence of cancer diagnosis (active or historical)
- •Age 18-85, Peripheral blood lymphocytes <5 x10^9/L
- •BMI of >=20kg/m2
- •ECOG Performance Status >=2
- •Not following any form of IF for 4 months prior to study
排除标准
- •Experimental and Control Participants:
- •Unable to give consent
- •On medications required to be taken with food during the fasting window
- •Pregnant or breastfeeding
- •Diabetes mellitus
- •BMI drop to < 18.5kg/m2 at any time during study
- •Anti-lymphoma therapy within the past 3 months
- •Expected to initiate anti-lymphoma therapy within the next 3 months
- •Unable to fast due to a digestive system disorder
- •> 85 years of age (due to frailty, increased risk of infection, and burden of additional blood collections)
研究组 & 干预措施
Experimental Group
Research Design: A nonrandomized control design will be followed with a 4:1 ratio (experimental: control). The experimental arm will consist of patients with early stage CLL who are on surveillance (n=60). Participants will follow a fasting intervention of an 8-hour feeding window with a 16-hour fasting window for a minimum of 6/7 days per week for either 3 months (90 days) or 6 months (180 days) based on their preference. Participants with cancer will provide blood samples, stool samples (optional) and will complete journals, check ins, and quality of life surveys per the schedule outlined in section 5.7 as well as in the attached study protocol document in section 6. Upon completion of study, participants with cancer may also complete an optional end of study interview.
干预措施: Time-Restricted Eating (Behavioral)
Control Group
The control arm will consist of community members who do not have cancer (n=15). Participants will follow a fasting intervention of an 8-hour feeding window with a 16-hour fasting window for a minimum of 6/7 days per week for either 3 months (90 days) or 6 months (180 days) based on their preference. Control participants will provide blood samples and weekly journals to serve as a control for autophagy flux analysis.
干预措施: Time-Restricted Eating (Behavioral)
结局指标
主要结局
Epigenetic Analysis via PBMC Profiling
时间窗: 3 months
PBMC Profiling
Blood Sample Lymphocyte Count
时间窗: 3 months
Lymphocyte count assessment will be made at pre-intervention (within 3 months of the start of the IF study period), then monthly. If participants opt for a 90-day fast, blood collections will be completed on day 1, 30, 60, 90 and one month after completion of the TRE study period, to examine if TRE had an effect on lymphocyte numbers. Participants who opt for the 180-day fast will complete blood collections on day 1, 30, 60, 90, 120, 150 and 180. Blood collected at these time points will be analyzed for autophagy activation and for changes in immune, inflammatory, metabolic and epigenetic parameters.
Blood Sample Autophagy Flux Analysis
时间窗: 3 months
Participants will provide blood samples for autophagy flux analysis.
Microbiome Analysis of Stool Samples
时间窗: 3 months
Optionally, stool samples will be collected for microbiome analysis.
次要结局
- Participant Experience: QLQ-30 and FACITF Questionnaires(3 months)
研究者
Eleah Stringer
Clinical and Research Dietitian
British Columbia Cancer Agency