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Prolonged Overnight Fasting and/or Exercise for the Improvement of Fatigue in Women with Advanced Hormone Receptor Positive Breast Cancer, FastER Trial
Trial Status: active
This clinical trial studies whether prolonged overnight fasting (POF) and/or exercise improve tiredness and lack of energy (fatigue) in women with hormone receptor positive (HR+) breast cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Standard treatment for advanced HR+ breast cancer includes an inhibitor of cyclin dependent kinase 4/6 (CDK4/6) in combination with endocrine therapy or a PI3K inhibitor. These standard treatments can often cause significant side effects, such as fatigue. Lifestyle interventions involving physical activity and diet may improve fatigue. POF is a type of intermittent fasting in which patients increase the time between dinner and breakfast and do not eat for 12-18 hours overnight. POF may have a positive impact on fatigue due to the alignment with the body's internal clock. Aerobic and resistance exercise is physical activity that improves physical fitness and involves increasing the heart rate or building strength using weights or other forms of resistance. POF and/or exercise may improve fatigue in women with advanced HR+ breast cancer.
Inclusion Criteria
Women
Able to provide written informed consent
Able to read and understand English or Spanish
Postmenopausal (including concurrent use of ovarian suppression)
Diagnosis of estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+), human epidermal growth factor receptor negative (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 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.
* 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 ≥ 12 hours [hr]/night) for the past 3 months
Approval from a medical oncology provider to participate
Exclusion Criteria
Unable to provide consent
Unable to read or understand English or Spanish
Oxygen dependent
Unstable cardiac disease
Insulin-dependent diabetes
Unable to walk 2 blocks without assistance (excluding canes)
Regularly maintaining a shiftwork schedule, i.e. working evening shifts, night shifts, or rotating shifts in the last 3 months
History of a clinical eating disorder
Unstable bone metastases
More than 90 days since initiation of first- or second-line endocrine therapy in combination with
* a CDK4/6 inhibitor, with or without HER2-directed therapy, or
* a CDK 4/6 inhibitor in combination with a PI3K inhibitor, in the metastatic or locally advanced
Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06123988.
Locations matching your search criteria
United States
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
I. To evaluate the impact of supervised exercise training and prolonged overnight fasting, alone or in combination, on fatigue in women with HR+ metastatic breast cancer initiating first- or second-line endocrine therapy in combination with either: a CDK4/6 inhibitor, with or without HER2-directed therapy, or a CDK4/6 inhibitor plus a PI3K inhibitor.
SECONDARY OBJECTIVES:
I. To evaluate the impact of supervised exercise training and prolonged overnight fasting, alone or in combination on sleep, treatment toxicities and patient reported outcomes (including depression, anxiety, quality of life), in women with HR+ metastatic breast cancer initiating first- or second-line endocrine therapy in combination with
either: a CDK4/6 inhibitor, with or without HER2-directed therapy, or a CDK4/6 inhibitor plus a PI3K inhibitor.
II. To evaluate the impact of supervised exercise training and prolonged overnight fasting, alone or in combination on inflammatory biomarkers (interleukin [IL]-6, tumor necrosis factor alpha [TNFa], c-reactive protien [CRP]) in women with HR+ metastatic breast cancer initiating first- or second-line endocrine therapy in combination with either: a CDK4/6 inhibitor, with or without HER2- directed therapy, or a CDK4/6 inhibitor plus a PI3K inhibitor.
EXPLORATORY OBJECTIVE:
I. To explore the relationship between circadian activity rhythms and 1) fatigue, sleep, depression, anxiety and quality of life and 2) physical function and body composition.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients complete a session with a nutrition health coach over 15-30 minutes once a week (QW) and receive instructions to follow POF guidelines with 12-14 hours of overnight fasting 6 nights per week for 12 weeks. Patients then complete nutrition health coach sessions monthly in months 4-6 and every other month in months 7-12. Patients also receive an informational nutrition workbook on study. Additionally, patients undergo blood sample collection throughout the study.
ARM II: Patients complete aerobic and resistance exercise sessions with a trainer over 60 minutes each three times a week (TIW) for 12 weeks. Patients then complete exercise sessions monthly in months 4-6 and every other month in months 7-12. Patients also receive a stationary bike, dumbbells, resistance bands, a Fitbit, and an informational exercise workbook on study. Additionally, patients undergo blood sample collection throughout the study.
ARM III: Patients complete aerobic and resistance exercise sessions with a trainer over 60 minutes each TIW as well as a session with a nutrition health coach over 15-30 minutes QW and receive instructions to follow POF guidelines with 12-14 hours of overnight fasting 6 nights per week for 12 weeks. Patients then complete exercise and nutrition health coach sessions monthly in months 4-6 and every other month in months 7-12. Patients also receive informational nutrition and exercise workbooks as well as a stationary bike, dumbbells, resistance bands, and a Fitbit on study. Additionally, patients undergo blood sample collection throughout the study.
ARM IV: Patients complete general health sessions with a supportive care coach over 15-30 minutes every other week for 12 weeks. Patients then complete general health sessions monthly in months 4-6 and every other month in months 7-12. Patients also receive an informational general health workbook on study as well as informational nutrition and exercise workbooks and a Fitbit at 6 months. Additionally, patients undergo blood sample collection throughout the study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
