U01CA271278

Trial of Exercise and Lifestyle (TEAL) in Women with Ovarian Cancer - Project Abstract/Summary

Ovarian cancer (OC) is the most lethal gynecologic malignancy, with disparities in survival by race. Nearly all stages of OC require aggressive treatment, such that first-line treatment includes surgery and six cycles of platinum- and taxane-based chemotherapy. Timely and successful completion of chemotherapy is critical, as delayed or reduced dosage for OC is associated with decreased survival. Yet, 90% of women diagnosed receive chemotherapy dose delays and dose reductions are common.

The primary reason for dose delays and reductions is chemotoxicity, including neuropathy, cognitive dysfunction, fatigue, depression, arthralgia, and gastrointestinal toxicities. Muscle loss is an additional consequence of chemotherapy in women with OC. Strategies to manage chemotoxicities include nutrition and exercise.

Our team has extensive experience in leading multi-site nutrition and exercise interventions in women with OC and relevant experience with trials specifically addressing chemotherapy completion rates. We will leverage this expertise to address a critical gap: how to reduce chemotoxicity and treatment delays in women with OC.

We propose to conduct a multi-site randomized trial of an 18-week nutrition therapy and exercise intervention vs. attention control in a racially and ethnically diverse group of 200 women newly diagnosed with OC (stage I-IV) and initiating curative intent chemotherapy. The aims of the study are as follows:

Aim 1: Assess relative dose intensity (RDI), an integrated measure of chemotherapy dose delays and reductions.
Aim 2: Evaluate patient-reported chemotoxicities including neuropathy, cognitive function, depression, fatigue, arthralgia, and gastrointestinal disturbances.
Aim 3: Measure body composition and muscle mass assessed via CT scans and urinary D3-creatinine dilution method.
Aim 4: Examine long-term lifestyle behaviors, body composition, patient-reported chemotoxicities, and health care utilization assessed 3 months post-intervention and 12 months post-diagnosis.

We hypothesize that women randomized to the intervention will have higher RDI compared to women in the attention control arm because of fewer patient-reported chemotoxicities. The intervention will result in attenuated declines in body composition compared with attention control, and women randomized to the intervention will maintain healthy lifestyle behaviors long-term, in turn favorably impacting lingering chemotoxicities and body composition, resulting in less health care utilization compared with attention control.

Strengths of our approach are that baseline, follow-up visits, and the intervention duration are timed with standard of care in that first-line chemotherapy is completed at ~18 weeks (when our primary endpoint will be assessed) with women undergoing repeat imaging assessments at this timepoint and 3 months later.

Positive results would accelerate a paradigm shift with OC patients receiving nutrition and exercise programming as standard of care in tandem with chemotherapy treatment to minimize chemotoxicity and optimize treatment dose delivery for a curative outcome.

Yale Univ

TO IMPROVE SCREENING AND EARLY DETECTION STRATEGIES AND TO DEVELOP ACCURATE DIAGNOSTIC TECHNIQUES AND METHODS FOR PREDICTING THE COURSE OF DISEASE IN CANCER PATIENTS. SCREENING AND EARLY DETECTION RESEARCH INCLUDES DEVELOPMENT OF STRATEGIES TO DECREASE CANCER MORTALITY BY FINDING TUMORS EARLY WHEN THEY ARE MORE AMENABLE TO TREATMENT. DIAGNOSIS RESEARCH FOCUSES ON METHODS TO DETERMINE THE PRESENCE OF A SPECIFIC TYPE OF CANCER, TO PREDICT ITS COURSE AND RESPONSE TO THERAPY, BOTH A PARTICULAR THERAPY OR A CLASS OF AGENTS, AND TO MONITOR THE EFFECT OF THE THERAPY AND THE APPEARANCE OF DISEASE RECURRENCE. THESE METHODS INCLUDE DIAGNOSTIC IMAGING AND DIRECT ANALYSES OF SPECIMENS FROM TUMOR OR OTHER TISSUES. SUPPORT IS ALSO PROVIDED FOR ESTABLISHING AND MAINTAINING RESOURCES OF HUMAN TISSUE TO FACILITATE RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. 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 BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.394 - Cancer Detection and Diagnosis Research

National Cancer Institute (NCI) [HHS - NIH]

New Haven, Connecticut 065103201 United States

Single Zip Code

Exercise and Nutrition Interventions to Improve Cancer Treatment-Related Outcomes (ENICTO) in Cancer Survivors Consortium (U01 Clinical Trial Required) (RFA-CA-21-031)

Amendment Since initial award the total obligations have increased 288% from $1,249,097 to $4,851,495.