This clinical trial studies whether a supervised home-based exercise program (Multidisciplinary Oncology Vitality and Exercise Program [MOVE]) improves side effects in patients receiving maintenance immunotherapy for non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Patients with non-small cell lung cancer often experience many side effects, including lack of energy, shortness of breath, pain, and depression. Patients often undergo treatments that can be demanding and can worsen or lead to more side effects. Cardiovascular exercise includes activities that focus on the improvement of the heart and blood vessels. Resistance training uses weight, or other forms of resistance, to induce muscle contraction and build strength, anaerobic endurance, and size of skeletal muscles. The MOVE program allows the patient to work with an exercise trainer virtually to complete cardiovascular and resistance training exercise sessions. Participating in the MOVE program may be an effective method to help patients receiving maintenance immunotherapy for advanced non-small cell lung cancer complete exercise sessions. This may help to improve side effects.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06513663.
Locations matching your search criteria
United States
Indiana
Indianapolis
Indiana University/Melvin and Bren Simon Cancer CenterStatus: Temporarily closed to accrual
Contact: Tarah J. Ballinger
Phone: 317-944-3553
PRIMARY OBJECTIVE:
I. To compare changes patient-reported fatigue (by Functional Assessment of Cancer Therapy: Fatigue [FACT-F] survey) from baseline to post- intervention in patients with locally advanced and advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
SECONDARY OBJECTIVES:
I. To compare changes in cardiorespiratory fitness measured by peak oxygen consumption (VO2peak), estimated as time on the treadmill during ramp treadmill test, from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
II. To compare changes in physical function measured by the short physical performance battery from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
III. To compare changes in muscle mass and muscle density measured on computed tomography (CT) scans for disease monitoring and bioimpedance analysis from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
IV. To compare changes in depression scores by Hospital Anxiety and Depression Scale (HADS) survey from baseline to post- intervention in patients with locally advanced and/or advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
V. To compare the proportion of patients who are “fatigued,” defined as a FACT-F score of < 43 at post-intervention between the exercise and usual care arms.
VI. To evaluate uptake and adherence of supervised home-based exercise program in patients with locally advanced and/or advanced lung cancer receiving maintenance immunotherapy or targeted therapy, measured by the percentage of patients who consented to the study and percentage of training sessions attended by patients in the exercise arm.
EXPLORATORY OBJECTIVES:
I. To explore the impact of exercise on circulating tumor cells in patients with non-small cell lung cancer (NSCLC) receiving maintenance immunotherapy.
II. To explore the impact of exercise on circulating T cell subsets in patients with NSCLC receiving maintenance immunotherapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients work virtually with an exercise trainer and complete cardiovascular exercise, resistance training, and balance or stretching exercise sessions over 60 minutes three times a week (TIW) for 12 weeks on study. Patients also undergo CT during screening and optionally on study. Additionally, patients undergo blood sample collection and CT throughout the study.
ARM II: Patients receive usual care per their treatment team throughout the study. Patients are also encouraged to exercise and receive usual care handouts at baseline. Patients also undergo CT during screening and optionally on study. Additionally, patients undergo blood sample collection and CT throughout the study.
After completion of study intervention, patients are followed up at days 84 and 168 and then every 6 months for 2 years.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorTarah J. Ballinger
