This clinical trial tests how well a personalized exercise and nutrition program works to improve cancer related fatigue in patients with slow growing (indolent) lymphoma. Cancer-related fatigue, characterized by an overwhelming sense of exhaustion that rest cannot relieve, is a frequently encountered symptom amongst patients battling indolent lymphomas. A combination of physical and nutritional guidance can lead to improved outcomes in cancer care, including fatigue, and can address the psychological and social challenges that contribute to the patient's overall burden of illness. Personalized exercise and nutrition programs may improve cancer related fatigue in patients with indolent lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06860880.
Locations matching your search criteria
United States
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer CenterStatus: Active
Contact: Christopher Edward Jensen
Phone: 919-966-0127
PRIMARY OBJECTIVE:
I. To investigate the feasibility of the referral and engagement process in fatigue mitigation intervention for cancer-related fatigue among adults with chronic lymphocytic leukemia (CLL) or other forms of indolent lymphoma.
SECONDARY OBJECTIVES:
I. To evaluate patient acceptability with the referral and engagement process in fatigue mitigation intervention cancer-related fatigue.
II. To assess changes in self-reported fatigue among subjects participating in the fatigue mitigation intervention.
III. To assess changes in self-reported overall health among subjects participating in the fatigue mitigation intervention.
EXPLORATORY OBJECTIVES:
I. To assess changes in physical function among subjects participating in the fatigue mitigation intervention.
II. To assess changes in endurance among subjects participating in the fatigue mitigation intervention.
III. To assess changes in muscle strength among subjects participating in the fatigue mitigation intervention.
IV. To assess changes in sleep quality among subjects participating in the fatigue mitigation intervention.
V. To assess pre- and post-intervention diet composition among subjects participating in the fatigue mitigation intervention.
VI. To assess changes in participant activation among subjects participating in the fatigue mitigation intervention.
VII. To assess changes in participant weight among subjects participating in the fatigue mitigation intervention.
VIII. To classify participants by frailty level.
IX. To assess subject compliance in the fatigue mitigation intervention.
X. To collect blood samples to describe immunological effects of fatigue mitigation intervention.
OUTLINE:
Patients undergo a rehabilitation consultation and receive an individualized exercise prescription with both aerobic and resistance training and may also receive support from a physical therapist if needed. Patients also receive nutritional consultation from a registered dietitian and personalized dietary recommendations. Patients undergo an additional meeting with the dietitian at week 4 and optionally at week 8 and undergo an additional meeting with rehabilitation at 4-8 weeks. Patients optionally undergo blood sample collection throughout the study.
After completion of the study intervention, patients follow up at 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorChristopher Edward Jensen