This clinical trial tests the effect of a diet and exercise program on fatigue in patients with chronic lymphocytic leukemia (CLL). Approximately 20,000 patients are diagnosed with CLL yearly and the median age is 72. Due to the average age of this diagnosis, having more than one disease at the same time (comorbidities) is common and can have a negative impact on quality of life and survival. Physical inactivity decreases physical functioning and can impact the ability to tolerate treatment. Improving diet and physical activity may improve the well-being and quality of life in patients with CLL.
Additional locations may be listed on ClinicalTrials.gov for NCT05879133.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Alessandra Ferrajoli
Phone: 713-792-2063
PRIMARY OBJECTIVE:
I. Evaluate the impact of an organized, longitudinal, diet and exercise training program on fatigue as assessed by the Functional Assessment of Cancer Therapy (FACT) score in patients with CLL.
SECONDARY OBJECTIVES:
I. Assess changes in physical activity, dietary behavior, physical function using the Patient Reported Outcomes Measurement Information System (PROMIS) physical function questionnaire and performance tests of physical function, body mass index (BMI) and global quality of life.
II. Assess changes in fecal microbiome composition, metabolic parameters including a comprehensive lipid panel, glucose, insulin, tumor necrosis factor (TNF) alpha, IL6, leptin, resistin, adiponectin, IGF1 and IGFBP1 and immunologic function as assessed by T cell and monocyte phenotypic and functional assays in patients with CLL after participation in the behavioral intervention.
EXPLORATORY OBJECTIVES:
I. Identify differences in the metabolic, immunologic and fecal microbiome composition in patients with CLL who have a high CLL comorbidity index score (CLL-CI) compared to patients with CLL and a low CLL-CI score.
II. Investigate the association of comorbidity score, disease features, CLL-specific prognostic factors and clinical outcomes.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients participate in resistance training assignments 10- 30 minutes daily for 26 weeks, watch video resistance training sessions on week 1 and 3, and receive motivational telephone coaching for 30-45 minutes once a week throughout study. Patients also receive National Diabetes Prevention Program (DPP) handouts after baseline assessment and monitor physical activity wearing Fitbit activity tracking device daily throughout study. Patients additionally undergo blood sample collection at baseline and week 13 after initiation of behavioral intervention.
GROUP II: Patients are placed on a waitlist until week 13 and then begin behavioral intervention as GROUP I. Patients additionally undergo blood sample collection baseline, and weeks 13 and 26 after initiation of behavioral intervention.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorAlessandra Ferrajoli
