Clinical trial NCT04708860: Feasibility of Fasting & Exercise in Pts With HR+ MBC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Metastatic Breast Cancer
Keywords: Breast Cancer
Metastatic Breast Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of enrollment
timeFrame: 12 months
measure: Rate of adherence to prolonged overnight fasting (POF) intervention goals
timeFrame: 12 weeks
measure: Rate of adherence to exercise intervention goals
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in metabolic biomarkers between baseline and week 12
timeFrame: 12 weeks
measure: Change in quality of life and patient-reported outcome measures between baseline and week 12
timeFrame: 12 weeks
measure: Differences in changes in metabolic biomarkers by treatment group (palbociclib vs palbocilib)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jennifer Ligibel, MD
role: PRINCIPAL_INVESTIGATOR
References: