Feasibility of Fasting & Exercise in Pts With HR+ MBC

Dana-Farber Cancer Institute

Status: Completed

Conditions: Breast Cancer; Metastatic Breast Cancer

Treatments: Behavioral: Prolonged Nightly Fasting; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04708860

20-503

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Diagnosis of diabetes requiring medication
• Engaging in >90 minutes of moderate or vigorous physical activity per week

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Prolonged Nightly Fasting Plus Exercise

Experimental group

Description:

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: * Prolonged overnight fasting: Not consume any calorie-containing food/drinks after 8pm, waiting a minimum of 13 hours after their last meal of the day before eating the next day, target goal of fasting at least 6 days a week, daily record of first and last meals * Exercise Program: Coach provided at-home, personalized exercise regimen with target goal of 120 minutes of moderate-intensity aerobic activity each week as well as two 30-45-minute virtual strength training classes per week, receive fitbit for exercise and heart rate monitoring, weekly telephone-based support sessions with coach.

Treatment:

Behavioral: Exercise

Behavioral: Prolonged Nightly Fasting