Feasibility of Fasting & Exercise in Pts With HR+ MBC
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|ClinicalTrials.gov Identifier: NCT04708860|
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : January 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic Breast Cancer||Behavioral: Prolonged Nightly Fasting Behavioral: Exercise||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Actual Study Start Date :||January 15, 2021|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||July 31, 2023|
Experimental: Prolonged Nightly Fasting Plus Exercise
Participants will be grouped into two cohorts determined by whether they receive palbociclib or alpelisib as part of their breast cancer treatment and then receive a 12 week prolonged nightly fasting plus exercise program consisting of:
Behavioral: Prolonged Nightly Fasting
Restriction of consumption of calorie-containing food/drinks after 8pm
Personalized moderate-intensity, aerobic exercise and strength training
- Rate of enrollment [ Time Frame: 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.
- Rate of adherence to prolonged overnight fasting (POF) intervention goals [ Time Frame: 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 [ Time Frame: 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.
- Changes in metabolic biomarkers between baseline and week 12 [ Time Frame: 12 weeks ]We will evaluate changes in fasting glucose, insulin, insulin resistance, hemoglobin A1c and other metabolic biomarkers in study participants between the baseline and end-of-intervention blood draws.
- Change in quality of life and patient-reported outcome measures between baseline and week 12 [ Time Frame: 12 weeks ]Quality of life will be evaluated for participants at baseline and at the end of the intervention using the EORTC QLQ C-30, sleep quality will be assessed via the Pittsburgh Sleep Quality Index (PSQI). Additional patient reported outcomes include the PRO-CTCAE, the 7-Day Physical Activity Recall and the 24-Hour Dietary Recall. We will assess changes in these measures between baseline and week 12 for study participants.
- Differences in changes in metabolic biomarkers by treatment group (palbociclib vs palbocilib) [ Time Frame: 12 weeks ]We will explore potential differences in changes in metabolic markers over the course of the 12-week POF and exercise intervention by treatment group (alpelisib vs palbociclib).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04708860
|Contact: Jennifer Ligibel, MD||617.632.3800||Jennifer_Ligibel@dfci.harvard.edu|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Jennifer Ligibel, MD 617-632-3800 Jennifer_Ligibel@dfci.harvard.edu|
|Principal Investigator: Jennifer Ligibel, MD|
|Principal Investigator:||Jennifer Ligibel, MD||Dana-Farber Cancer Institute|