RECRUITING

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

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Conditions

HER2-positive Breast CancerAdvanced Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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 (e.g., palbociclib, ribociclib, or abemaciclib), with or without HER2-directed therapy (e.g., trastuzumab ± pertuzumab), or in combination with both a CDK4/6 inhibitor and a PI3K inhibitor, within the past 90 days.

Official Title

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

Quick Facts

Study Start:2024-09-09
Study Completion:2029-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06123988

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Women
  2. 2. Able to provide written informed consent
  3. 3. Able to speak, read, and understand English or Spanish
  4. 4. Postmenopausal (including concurrent use of ovarian suppression)
  5. 5. Diagnosis of ER+ and/or PR+, hormone estrogen receptor-2 (HER-2)- or HER-2+ metastatic or locally advanced unresectable breast cancer
  6. 6. Initiation of first-line or second-line endocrine therapy in combination with a CDK4/6 inhibitor (e.g., palbociclib, ribociclib, or abemaciclib), with or without hormone estrogen receptor-2 (HER2)-directed therapy (e.g., trastuzumab ± pertuzumab), or in combination with both a CDK4/6 inhibitor and a Phosphoinositide 3-kinase (PI3K) inhibitor, within the past 90 days.
  7. 1. Prior use of a CDK4/6 inhibitor in the adjuvant setting is permitted; participants must be enrolled within 90 days of starting a CDK4/6 inhibitor for the first or second time in the metastatic or locally advanced setting.
  8. 2. Participants who switch from one CDK4/6 inhibitor to another due to toxicity or insurance constraints remain eligible, provided enrollment occurs within 90 days of initiating the first or second-line CDK4/6 inhibitor in the metastatic or locally advanced setting.
  9. 7. Having not consistently (not equal to or more than 50% of the time) engaged in more than 90 minutes of moderate or 45 minutes of vigorous physical activity per week over the past 3 months
  10. 8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months
  11. 9. Having not consistently (not equal to or more than 50% of the time) engaged in structured fasting (i.e., not regularly fasting for ≥12hr/night) for the past 3 months
  12. 10. Approval from a medical oncology provider to participate.
  1. 1. Unable to provide consent
  2. 2. Unable to read or understand English or Spanish
  3. 3. Oxygen dependent
  4. 4. Unstable cardiac disease
  5. 5. Insulin-dependent diabetes
  6. 6. Unable to walk 2 blocks without assistance (excluding canes)
  7. 7. Regularly maintaining a shiftwork schedule, i.e. working evening shifts, night shifts, or rotating shifts in the last 3 months
  8. 8. History of a clinical eating disorder
  9. 9. Unstable bone metastases
  10. 10. More than 90 days since initiation of first- or second-line endocrine therapy in combination with 1) a CDK4/6 inhibitor, with or without HER2-directed therapy, or 2) a CDK 4/6 inhibitor in combination with a PI3K inhibitor, in the metastatic or locally advanced.
  11. 11. Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention.

Contacts and Locations

Study Contact

Grey Freylersythe, BS
CONTACT
(305) 243-9832
g.freylersythe@med.miami.edu
Tracy E Crane, PhD, RDN
CONTACT
(305) 243-8255
tecrane@med.miami.edu

Principal Investigator

Tracy E Crane, PhD, RDN
PRINCIPAL_INVESTIGATOR
University of Miami
Carmen Calfa, MD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

Arizona State University
Phoenix, Arizona, 85004
United States
University of Miami
Miami, Florida, 33136
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Tracy E Crane, PhD, RDN, PRINCIPAL_INVESTIGATOR, University of Miami
  • Carmen Calfa, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-09
Study Completion Date2029-09-30

Study Record Updates

Study Start Date2024-09-09
Study Completion Date2029-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • HER2-positive Breast Cancer
  • Advanced Breast Cancer