Pilot Study of the Impact of a Combined Intermittent Fasting and Exercise Intervention on Metabolic Markers in Patients With Advanced, Hormone Receptor Positive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Rate of adherence to prolonged overnight fasting (POF) intervention goals
研究概览
简要总结
This research is evaluating the impact of a 12-week prolonged nightly fasting (POF) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib.
详细描述
This is single-arm feasibility pilot study exploring whether a combined prolonged nightly fasting (POF) and exercise program could impact hyperglycemia and other adverse metabolic consequences of PI3 kinase inhibitors in women with metastatic breast cancer (MBC).
Women who exercise regularly and who have lower levels of blood sugar and metabolic hormones like insulin have a lower risk of developing breast cancer. Some evidence also suggests that exercise and metabolism are related to cancer recurrence in women who are diagnosed with breast cancers that can be removed with surgery, but less is known about how exercise and metabolic factors are related to cancer progression in women whose cancer has advanced beyond the breast and underarm lymph nodes. This study is designed to look at the effects of exercise combined with prolonged nightly fasting (having a longer time between dinner and breakfast the next day), on blood sugar and hormones that control metabolism. This study looks to provide important information about whether making these kinds of changes is possible for women living with advanced breast cancer and will explore how making these changes effects blood sugar and hormone levels in women taking different kinds of treatments for advanced breast cancer.
The research study procedures include screening for eligibility, a baseline visit to collect information about diet and exercise habits, a baseline blood draw, participation in a 12-week diet and exercise program, and a follow up visit and blood collection at the end of the diet and exercise program.
Participants will be in this research study for up to 14-weeks, including the baseline and end of study visits to collect study measures.
It is expected that about 30 people will take part in this research study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Diagnosis of ER and/or PR+ metastatic or locally unresectable breast cancer
- •Postmenopausal (including concurrent use of ovarian suppression)
- •Initiating endocrine therapy in combination with:
- •Cohort 1: alpelisib
- •Cohort 2: palbociclib
- •Self-reported ability to walk two blocks
- •> 18 years of age
- •Approval from treating oncologist, confirmed via email or in writing
- •Ability to read and understand English
排除标准
- •Diagnosis of diabetes requiring medication
- •Engaging in >90 minutes of moderate or vigorous physical activity per week
结局指标
主要结局
Rate of adherence to prolonged overnight fasting (POF) intervention goals
时间窗: 12 weeks
Feasibility will additionally be defined by participants achieving POF intervention goals on 70% of days by week 12.
Rate of adherence to exercise intervention goals
时间窗: 12 weeks
Feasibility will also be defined by at least 70% of participants achieving 120 minutes of aerobic exercise plus 2 strength training classes per week by week 12.
Rate of enrollment
时间窗: 12 months
The primary objective is to evaluate the feasibility of the intervention. Feasibility will be defined by the rate of enrollment and the intervention will be considered feasible if at least 80% of planned participants are enrolled within 12 months of study activation.
次要结局
- Change in quality of life and patient-reported outcome measures between baseline and week 12(12 weeks)
- Differences in changes in metabolic biomarkers by treatment group (palbociclib vs palbocilib)(12 weeks)
- Changes in metabolic biomarkers between baseline and week 12(12 weeks)
研究者
Jennifer A. Ligibel, MD
Principal Investigator
Dana-Farber Cancer Institute