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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Women

• Able to provide written informed consent

• Able to speak, read, and understand English or Spanish

• Postmenopausal (including concurrent use of ovarian suppression)

• Diagnosis of ER+ and/or PR+, hormone estrogen receptor-2 (HER-2)- or HER-2+ metastatic or locally advanced unresectable breast cancer

• 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.

∙ 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.

‣ 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.

• 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

• Having not consistently engaged in resistance training 2 or more days per week over the past 3 months

• 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

⁃ Approval from a medical oncology provider to participate.

Locations
United States
Arizona
Arizona State University
NOT_YET_RECRUITING
Phoenix
Florida
University of Miami
RECRUITING
Miami
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Grey Freylersythe, BS
g.freylersythe@med.miami.edu
(305) 243-9832
Backup
Tracy E Crane, PhD, RDN
tecrane@med.miami.edu
(305) 243-8255
Time Frame
Start Date: 2024-09-09
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 260
Treatments
Experimental: Prolonged Overnighting Fasting Alone (POF Alone) Group
Participants in this group will undergo a 12-week program of prolonged overnight fasting (POF), and weekly session with a trained health coach. Sessions may be delivered in-person, by telephone or by video call. Participants will also complete health-related quality of life questionnaires, and undergo blood sample collection at designated study timepoints.~Total participant duration is about 12 months.
Active_comparator: Exercise Alone (EXE Alone) Group
Participants in this group will undergo a 12-week exercise program during three weekly sessions supervised by a trained health coach. Sessions may be delivered in-person, or virtually via telehealth. Participants will also complete health-related quality of life questionnaires, and undergo blood sample collection at designated study timepoints.~Total participant duration is about 12 months.
Active_comparator: Prolonged Overnight Fasting and Exercise (POF+EXE) Group
Participants in this group will undergo a 12-week combined program of the prolonged overnight fasting and exercise interventions as described in the POF Alone and EXE Alone arm descriptions respectively. Participants will complete health-related quality of life questionnaires, and undergo blood sample collection at designated study timepoints.~Total participation is about 12 months.
Other: Attention Control (AC) Group
Participants in this group will receive other supportive care in the form of general health education sessions with a trained health coach. These bi-weekly sessions will be administered via telephone or video call in six (6) sessions over approximately 12 weeks. Participants will also complete health-related quality of life questionnaires at designated study timepoints.~Total participation is about 12 months.
Related Therapeutic Areas
Sponsors
Leads: University of Miami
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov