Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility of Fasting & Exercise in Pts With HR+ MBC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04708860
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Metastatic Breast Cancer Behavioral: Prolonged Nightly Fasting Behavioral: Exercise Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:

  • 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.
Behavioral: Prolonged Nightly Fasting
Restriction of consumption of calorie-containing food/drinks after 8pm

Behavioral: Exercise
Personalized moderate-intensity, aerobic exercise and strength training




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Jennifer Ligibel, MD 617.632.3800 Jennifer_Ligibel@dfci.harvard.edu

Locations
Layout table for location information
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         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Layout table for investigator information
Principal Investigator: Jennifer Ligibel, MD Dana-Farber Cancer Institute
Layout table for additonal information
Responsible Party: Jennifer A. Ligibel, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04708860    
Other Study ID Numbers: 20-503
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute:
Breast Cancer
Metastatic Breast Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases