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Behavioral Intervention
Fasting + Exercise for Advanced Breast Cancer (FastER Trial)
N/A
Waitlist Available
Led By Tracy E Crane, PhD, RDN
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of ER+ and/or PR+, hormone estrogen receptor-2 (HER-2)- metastatic or locally advanced unresectable breast cancer
Postmenopausal (including concurrent use of ovarian suppression)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks, 6 months and 12 months
Awards & highlights
FastER Trial Summary
This trial tests if fasting, exercise, or health education can reduce fatigue in women with advanced breast cancer on CDK4/6 inhibitor therapy.
Who is the study for?
This trial is for postmenopausal women with advanced breast cancer who are starting or have recently started treatment with CDK4/6 inhibitors. They should not be regularly exercising vigorously, fasting overnight, or doing resistance training. Participants must be able to consent and understand English or Spanish.Check my eligibility
What is being tested?
The study tests four approaches: prolonged overnight fasting, exercise, both combined, and general health education sessions to see if they reduce fatigue in women taking CDK4/6 inhibitors for advanced breast cancer.See study design
What are the potential side effects?
Potential side effects may include discomfort from changing eating patterns due to fasting or muscle soreness from new exercise routines. General health education sessions likely have no side effects.
FastER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is ER+ or PR+, HER-2-, and cannot be removed by surgery.
Select...
I am postmenopausal or using ovarian suppression.
FastER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks, 6 months and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks, 6 months and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Cancer-Related Fatigue as Measured by EORTC QLQ-C30 Scores
Secondary outcome measures
Change in Body Composition as measured in Hounsfield using PET Scan
Change in Body Composition measured in Hounsfield using CT Scan
Change in Incidence of Toxicity as Measured by PRO-CTCAE Scores
+7 moreFastER Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Prolonged Overnighting Fasting Alone (POF Alone) GroupExperimental Treatment1 Intervention
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.
Group II: Attention Control (AC) GroupExperimental Treatment1 Intervention
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.
Group III: Prolonged Overnight Fasting and Exercise (POF+EXE) GroupActive Control2 Interventions
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.
Group IV: Exercise Alone (EXE Alone) GroupActive Control1 Intervention
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.
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Who is running the clinical trial?
University of MiamiLead Sponsor
902 Previous Clinical Trials
409,816 Total Patients Enrolled
17 Trials studying Breast Cancer
1,551 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,181 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Tracy E Crane, PhD, RDNPrincipal InvestigatorUniversity of Miami
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this scientific endeavor open to new participants?
"The research project, originally posted on December 31st 2023 and last updated November 8th 2023, is no longer recruiting candidates. However, there are over two thousand four hundred fifty one other medical trials that are actively looking for participants."
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