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

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)

Overview

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.

Interventions

• Behavioral 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
• Behavioral 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 3
• Behavioral 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 ca

Primary outcome measures

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

Secondary outcome measures (10)

• Change in Sleep Quality as Measured by Pittsburgh Sleep Quality Index (PSQI) Scores [Time frame: Baseline, 12 weeks, 6 months, and 12 months]
• Change in Incidence of Toxicity as Measured by PRO-CTCAE Scores [Time frame: Baseline, 12 weeks, 6 months, and 12 months]
• Change in Levels of Psychological Distress as Measured by Patient Health Questionnaire (PHQ-4) Scores [Time frame: Baseline, 12 weeks, 6 months, and 12 months]
• Change in Quality of Life as Measured by EORTC QLQ-C30 Scores [Time frame: Baseline, 12 weeks, 6 months, and 12 months]
• Change in Physical Function as Measured by Short Physical Performance Battery (SPPB) Test [Time frame: Baseline, 12 weeks, 6 months, and 12 months]
• Change in Body Composition measured in Hounsfield using CT Scan [Time frame: Baseline, 12 weeks, 6 months, and 12 months]
• Change in Body Composition as measured in Hounsfield using PET Scan [Time frame: Baseline, 12 weeks, 6 months, and 12 months]
• Change in Levels of Interleukin-6 (IL-6) [Time frame: Baseline, 12 weeks, 6 months and 12 months]
• Change in Levels of Tumor necrosis factor alpha (TNF-α) levels [Time frame: Baseline, 12 weeks, 6 months and 12 months]
• Change in Levels of C-reactive protein (CRP) [Time frame: Baseline, 12 weeks, 6 months and 12 months]

Eligibility criteria

Inclusion criteria

• 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.

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 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.
• Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 3 centers

• Arizona State University — Phoenix
• University of Miami — Miami
• Dana-Farber Cancer Institute — Boston

Identifiers

NCT: NCT06123988 · 20230599 · R01CA281861

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗