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Feasibility of Fasting & Exercise in Pts With HR+ MBC

Primary Purpose

Breast Cancer, Metastatic Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Nightly Fasting
Exercise
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prolonged Nightly Fasting Plus Exercise

Arm 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.

Outcomes

Primary Outcome Measures

Rate of enrollment
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
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
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.

Secondary Outcome Measures

Changes in metabolic biomarkers between baseline and week 12
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
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)
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).

Full Information

First Posted
January 4, 2021
Last Updated
October 16, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04708860
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Metastatic Breast Cancer
Keywords
Breast Cancer, Metastatic Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolonged Nightly Fasting Plus Exercise
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Nightly Fasting
Intervention Description
Restriction of consumption of calorie-containing food/drinks after 8pm
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Personalized moderate-intensity, aerobic exercise and strength training
Primary Outcome Measure Information:
Title
Rate of enrollment
Description
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.
Time Frame
12 months
Title
Rate of adherence to prolonged overnight fasting (POF) intervention goals
Description
Feasibility will additionally be defined by participants achieving POF intervention goals on 70% of days by week 12.
Time Frame
12 weeks
Title
Rate of adherence to exercise intervention goals
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in metabolic biomarkers between baseline and week 12
Description
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.
Time Frame
12 weeks
Title
Change in quality of life and patient-reported outcome measures between baseline and week 12
Description
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.
Time Frame
12 weeks
Title
Differences in changes in metabolic biomarkers by treatment group (palbociclib vs palbocilib)
Description
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).
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Ligibel, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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Feasibility of Fasting & Exercise in Pts With HR+ MBC

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