Clinical trial NCT06123988: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HER2-positive Breast Cancer
Advanced Breast Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-11-09
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Women
2. Able to provide written informed consent
3. Able to 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)- metastatic or locally advanced unresectable breast cancer
6. Initiating first-line or second-line endocrine therapy in combination with a CDK4/6 inhibitor (e.g. palbociclib, ribociclib or abemaciclib). Participants can be enrolled up to 2 weeks after starting CDK4/6 inhibitor
7. Having not consistently 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 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. Oxygen dependent
4. Unstable cardiac disease
5. Insulin-dependent diabetes
6. Unable to walk 2 blocks without assistance (excluding canes)
7. Unstable bone metastases
8. More than 15 days from initiation of first- or second-line endocrine therapy in combination with a CDK4/6 inhibitor

Primary outcomes:
measure: Change in Cancer-Related Fatigue as Measured by EORTC QLQ-C30 Scores
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in Sleep Quality as Measured by Pittsburgh Sleep Quality Index (PSQI) Scores
timeFrame: Baseline, 12 weeks, 6 months, and 12 months
measure: Change in Incidence of Toxicity as Measured by PRO-CTCAE Scores
timeFrame: Baseline, 12 weeks, 6 months, and 12 months
measure: Change in Levels of Psychological Distress as Measured by Patient Health Questionnaire (PHQ-4) Scores
timeFrame: Baseline, 12 weeks, 6 months, and 12 months
measure: Change in Quality of Life as Measured by EORTC QLQ-C30 Scores
timeFrame: Baseline, 12 weeks, 6 months, and 12 months
measure: Change in Physical Function as Measured by Short Physical Performance Battery (SPPB) Test
timeFrame: Baseline, 12 weeks, 6 months, and 12 months
measure: Change in Body Composition measured in Hounsfield using CT Scan
timeFrame: Baseline, 12 weeks, 6 months, and 12 months
measure: Change in Body Composition as measured in Hounsfield using PET Scan
timeFrame: Baseline, 12 weeks, 6 months, and 12 months
measure: Change in Levels of Interleukin-6 (IL-6)
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Change in Levels of Tumor necrosis factor alpha (TNF-α) levels
timeFrame: Baseline, 12 weeks, 6 months and 12 months
measure: Change in Levels of C-reactive protein (CRP)
timeFrame: Baseline, 12 weeks, 6 months and 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: University of Miami
name: Tracy E Crane, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Carmen Calfa, MD
role: PRINCIPAL_INVESTIGATOR
References: