This clinical trial assesses the impact of a guided nutrition and exercise program (LIFE) in alleviating the side effects of chemotherapy in patients with lymphoma. Side effects from chemotherapy are very common, occurring in up to 75% of lymphoma patients, and can often delay or reduce chemotherapy treatment. A delay or reduction in chemotherapy can have a major impact on how effective treatment will be. Overall, the benefits of lifestyle modifications in diet and physical exercise in cancer survivors have been proven for a variety of cancers, but evidence involving benefits for lymphoma survivors is scarce. This study may help researchers learn about how diet and exercise may impact the side effects of chemotherapy and improve treatment completion in patients with lymphoma, as well as how to better support these patients in the future.
Additional locations may be listed on ClinicalTrials.gov for NCT05839210.
Locations matching your search criteria
United States
Florida
Aventura
UM Sylvester Comprehensive Cancer Center at AventuraStatus: Active
Contact: Tracy E Crane
Phone: 520-331-0120
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral GablesStatus: Active
Contact: Tracy E Crane
Phone: 520-331-0120
Coral Springs
UM Sylvester Comprehensive Cancer Center at Coral SpringsStatus: Active
Contact: Tracy E Crane
Phone: 520-331-0120
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield BeachStatus: Active
Contact: Tracy E Crane
Phone: 520-331-0120
Hollywood
UM Sylvester Comprehensive Cancer Center at HollywoodStatus: Active
Contact: Tracy E Crane
Phone: 520-331-0120
Miami
University of Miami Miller School of Medicine-Sylvester Cancer CenterStatus: Active
Contact: Tracy E Crane
Phone: 305-243-8255
UM Sylvester Comprehensive Cancer Center at KendallStatus: Active
Contact: Tracy E Crane
Phone: 520-331-0120
Plantation
UM Sylvester Comprehensive Cancer Center at PlantationStatus: Active
Contact: Tracy E Crane
Phone: 520-331-0120
PRIMARY OBJECTIVE:
I. Feasibility and acceptability of the intervention, and retention at the end of the study.
SECONDARY OBJECTIVE:
I. To assess the preliminary efficacy of the intervention on relative dose intensity (RDI), an integrated measure of chemotherapy dose delays, reductions, and overall treatment tolerance.
EXPLORATORY OBJECTIVES:
I. To assess the preliminary efficacy of the intervention on patient-reported chemotoxicities including neuropathy, cognitive function, depression, fatigue, arthralgia, and gastrointestinal disorders.
II. To explore changes in body composition and metabolic and inflammatory markers over the course of treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in the LIFE program and receive 2 health coaching sessions, consume a Mediterranean diet, and undergo a structured home-based aerobic and resistance exercise program on study. Patients receive supportive materials consisting of an informational study notebook, exercise reference posters/videos, resistance bands, and text messages on study. Patients receive a Fitbit to self-monitor their daily physical activity and use the MyFitnessPal app to track their diet on study. Patients also undergo the collection of blood samples on study.
ARM II: Patients receive usual care on study. Patients may then receive all study materials and 2 health coaching sessions at the end of the study. Patients also undergo the collection of blood samples on study.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorTracy E Crane
