Prolonged Overnight Fasting And/or Exercise on Fatigue and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer

Description

The purpose of this study is to test if four different programs (prolonged overnighting fasting alone, exercise alone, a combination of prolonged overnight fasting and exercise, or general health education sessions alone) can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a cyclin-dependent kinases-4 and 6 (CDK4/6) inhibitor.

Conditions

HER2-positive Breast Cancer, Advanced Breast Cancer

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Study Overview

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Study Details

Study overview

The purpose of this study is to test if four different programs (prolonged overnighting fasting alone, exercise alone, a combination of prolonged overnight fasting and exercise, or general health education sessions alone) can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a cyclin-dependent kinases-4 and 6 (CDK4/6) inhibitor.

Prolonged Overnight Fasting And/or Exercise on Fatigue and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer (FastER)

Prolonged Overnight Fasting And/or Exercise on Fatigue and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer

Condition
HER2-positive Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Phoenix

Arizona State University, Phoenix, Arizona, United States, 85004

Miami

University of Miami, Miami, Florida, United States, 33136

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Women
  • 2. Able to provide written informed consent
  • 3. Able to read and understand English or Spanish
  • 4. Postmenopausal (including concurrent use of ovarian suppression)
  • 5. Diagnosis of ER+ and/or PR+, hormone estrogen receptor-2 (HER-2)- metastatic or locally advanced unresectable breast cancer
  • 6. Initiating first-line or second-line endocrine therapy in combination with a CDK4/6 inhibitor (e.g. palbociclib, ribociclib or abemaciclib). Participants can be enrolled up to 2 weeks after starting CDK4/6 inhibitor
  • 7. Having not consistently engaged in more than 90 minutes of moderate or 45 minutes of vigorous physical activity per week over the past 3 months
  • 8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months
  • 9. Having not consistently engaged in structured fasting (i.e., not regularly fasting for ≥12hr/night) for the past 3 months
  • 10. Approval from a medical oncology provider to participate.
  • 1. Unable to provide consent
  • 2. Unable to read or understand English or Spanish
  • 3. Oxygen dependent
  • 4. Unstable cardiac disease
  • 5. Insulin-dependent diabetes
  • 6. Unable to walk 2 blocks without assistance (excluding canes)
  • 7. Unstable bone metastases
  • 8. More than 15 days from initiation of first- or second-line endocrine therapy in combination with a CDK4/6 inhibitor

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Miami,

Tracy E Crane, PhD, RDN, PRINCIPAL_INVESTIGATOR, University of Miami

Carmen Calfa, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2029-09-30