Recruiting

Fasting & Exercise

Sponsor:

University of Miami

Code:

NCT06123988

Conditions

HER2-positive Breast Cancer

Advanced Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prolonged Overnight Fasting

Moderate-Intensity Exercise

General Health Education Sessions

Study Details

Brief summary:

The purpose of this study is to test whether four different supportive care programs can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) alongwith endocrine therapy with or without a PI3K or AKT inhibitor.

Conditions

HER2-positive Breast Cancer

Advanced Breast Cancer

Study ID

NCT06123988

Start date

Sep 9, 2024

Status verified date

Aug, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Women
2. Able to provide written informed consent
3. Able to speak, 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)- or HER-2+ metastatic or locally advanced unresectable breast cancer
6. Initiation of 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) or Protein kinase B (AKT) inhibitor, within the past 90 days.

a) 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 subsequent CDK4/6 inhibitor in the metastatic or locally advanced setting.
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
8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months
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
10. Approval from a medical oncology provider to participate.

Exclusion Criteria:

1. Unable to provide consent
2. Unable to read or understand English or Spanish
3. Dependent on supplemental oxygen
4. Unstable cardiac disease
5. Insulin-dependent diabetes
6. Unable to walk 2 blocks without assistance (excluding canes)
7. Regularly maintaining a shiftwork schedule, i.e. working evening shifts, night shifts, or rotating shifts in the last 3 months
8. History of a clinical eating disorder
9. Unstable bone metastases
10. More than 90 days since initiation of 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/AKT inhibitor, in the metastatic or locally advanced.
11. Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention.

Study Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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 receive a Fitbit (activity monitor). 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 receive a Fitbit (activity monitor). Participants will receive exercise equipment (resistance bands, adjustable dumbbells, and a stationary aerobic bike) free of charge and may keep it after the study's completion. 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 receive a Fitbit (activity monitor). Participants will receive exercise equipment (resistance bands, adjustable dumbbells, and a stationary aerobic bike) free of charge and may keep it after the study's completion. 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 receive a Fitbit (activity monitor). Participants will also complete health-related quality of life questionnaires at designated study timepoints.

Total participation is about 12 months.

Interventions

Prolonged Overnight Fasting

Participants will undergo a 12-week program of prolonged overnight fasting (POF) during which they will abstain from consuming food or drink after 8pm, and wait 12 to 14 hours before resuming eating the next day. Participants will fast overnight for six nights each week, with one night off, and log their fasting start and stop times and timing of food intake daily via text messaging, or via study-provided app accessible by web browser or smart phone, or via paper journal returned by mail at the end of each month.

Participants will also complete one weekly session with a health coach to review their fasting log and any barriers to and/or facilitators of meeting the POF goals. Sessions may be delivered in-person, by telephone, or by video call based on participant preference. Sessions will last 15 to 30 minutes each, for a total of 12 sessions.

Participants will be provided with a notebook with information and support to encourage meeting the POF goals.

Moderate-Intensity Exercise

Participants will undergo a 12-week program consisting of three weekly sessions of moderate-to-vigorous aerobic and resistance exercises, under the supervision of a health coach. Sessions may be delivered either in-person or virtually via telehealth. Sessions will be tailored to the individual participant based on fitness level and symptoms at study entry, and limited to daylight hours as much as possible. Each session will last 30 to 50 minutes, as tolerated by the participant, for a total of 36 sessions.

Participants will receive a Fitbit device to track their activity, and to provide heart rate monitoring during each session. Participants without access to wi-fi will be loaned cellular-enabled tablets to allow them to participate in telehealth sessions. Participants will also receive a notebook with information and support to encourage exercise.

General Health Education Sessions

Participants will receive a general health education resource manual at study entry, followed by six bi-weekly sessions with a health coach to review the information. Six topics, one topic for each session, will be selected based on topics of potential interest to a population living with advanced breast cancer, focusing on general nutrition, healthy lifestyle, and quality of life, with no discussion of prolonged overnight fasting or exercise. Each session, administered via telephone or video call, will last about 15 to 30 minutes, and have a specific topic and call script for the health coach to follow to minimize any intervention drift and/or contamination. Participants will receive a Fitbit activity monitoring device and additional study materials at the end of their participation in the study.

Primary outcome measure

  • Change in Cancer-Related Fatigue as Measured by EORTC QLQ-C30 Scores [ Time Frame: Baseline, 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Tracy E Crane, PhD, RDN

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Christina Dieli-Conwright, PhD, MPI

More Information

Sponsor

University of Miami

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-26.