R01CA281861

Randomized Phase II Trial of Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer (FASTER) - Abstract

More than 40,000 women die each year of metastatic breast cancer. The majority of these tumors are hormone receptor positive (HR+) that are treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor in combination with an aromatase inhibitor or fulvestrant. With these treatments, women with advanced breast cancer are living longer, but treatment-related toxicities inevitably occur, and quality of life is limited by side effects of cancer treatment which may result in dose reductions and delays.

Fatigue is the most commonly cited adverse side effect reported for women taking CDK4/6 inhibitors and mechanistically may be associated with inflammation. When unmanaged, fatigue is debilitating, directly impacting both psychological and physical quality of life and a key driver in discontinuation of therapy.

Lifestyle interventions targeting diet and exercise have evidence for improving fatigue in early stage breast cancer. However, whether these strategies are efficacious for improving outcomes in women with advanced breast cancer remains unknown, with even less information for women from underrepresented backgrounds, who suffer disproportionately from breast cancer and its treatment.

Research regarding the impact of these strategies on high-grade fatigue induced by CDK4/6 inhibitors in advanced disease from a diverse patient population are needed.

The Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer (FASTER) study will evaluate a Phase II, 2 x 2 randomized controlled trial testing the effects of a prolonged overnight fasting (POF) intervention alone, moderate-intensity exercise alone, or in combination, on fatigue in 260 women with advanced breast cancer initiating treatment with hormonal therapy in combination with a CDK4/6 inhibitor.

Participants would undergo assessment of fatigue and associated inflammatory biomarkers, as well as assessment of physical activity, diet, physical function, body composition, and patient-reported outcomes at baseline (prior to the initiation of CDK4/6 inhibitor) and 12 weeks (post-intervention), 6 and 12 months after study enrollment.

The primary outcome of the study is to evaluate the impact of the interventions (vs control) on fatigue in women at 12 weeks. Secondary outcomes include inflammatory biomarkers, patient-reported outcomes, physical function, and body composition.

The FASTER study will also explore the impact of the intervention on circadian rhythms, fatigue, sleep, depression, anxiety, quality of life, physical function, and body composition.

The overarching goal of the FASTER study is to determine whether prolonged overnight fasting or moderate-intensity exercise alone or in combination can mitigate the adverse consequences of treatment and improve fatigue and other outcomes in women with advanced breast cancer treated with CDK4/6 inhibitors to ultimately improve both quantity and quality of life for this growing population of women.

University Of Miami

TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS, (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION, (3) EPIDEMIOLOGY, (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS, (5) IMMUNOLOGY AND VACCINES, (6) FIELD STUDIES AND STATISTICS, (7) CANCER CHEMOPREVENTION AND INTERCEPTION, (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT, (9) ORGAN SITE STUDIES AND CLINICAL TRIALS, (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES, AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO STIMULATE TECHNICAL INNOVATION, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.

93.393 - Cancer Cause and Prevention Research

National Cancer Institute (NCI) [HHS - NIH]

Miami, Florida 331362107 United States

Single Zip Code

Research to Understand and Address the Survivorship Needs of Individuals Living with Advanced Cancer (R01 Clinical Trial Optional) (RFA-CA-22-027)

Amendment Since initial award the total obligations have increased 366% from $810,559 to $3,777,161.