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NCT06513663 | RECRUITING | Lung Cancer

Exercise as Maintenance Therapy in Advanced Lung Cancer
Sponsor:

Indiana University

Information provided by (Responsible Party):

Tarah j Balllinger, MD

Brief Summary:

The purpose of this study is to examine how a multimodality (having or using a variety of methods to do something) exercise intervention may improve survival, function, and quality of life in participants with advanced lung cancer.

Condition or disease

Lung Cancer

Non Small Cell Lung Cancer

Metastatic Lung Cancer

Intervention/treatment

Exercise Intervention

Phase

NA

Detailed Description:

This study is a randomized control trial at a single institution comparing advanced lung cancer patients undergoing supervised home-based exercise program versus usual care. The intervention is a supervised home-based exercise program that will be coordinated by the MOVE program. The regimen will be 12 weeks in duration, three times a week, and administered by a trained professional virtually. Participants will be randomized 1:1 to the exercise or usual care arm. Participants will be stratified on baseline frailty by the SPPB. Primary Objective To compare changes patient-reported fatigue (by 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 1. To compare changes in cardiorespiratory fitness measured by 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. 2. 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. 3. To compare changes in muscle mass and muscle density measured on 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. 4. To compare changes in depression scores by 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. 5. 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. 6. 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Exercise as Maintenance Therapy in Advanced Lung Cancer
Actual Study Start Date : 2024-10-15
Estimated Primary Completion Date : 2029-12
Estimated Study Completion Date : 2029-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Age ≥ 18 years
  • 2. Known diagnosis of locally advanced (stage III) or metastatic NSCLC
  • 3. Patient is currently receiving maintenance immunotherapy for at least 1 month and planned for at least 3 additional months of therapy
  • 1. Patients receiving maintenance therapy refers to patients with stable disease or partial response to therapy, including patients who have had a history of disease progression but are currently stable or responding to a different therapy
  • 2. Patients previously receiving chemotherapy are eligible as long as at least one month has elapsed since completing chemotherapy. Those currently receiving chemotherapy are not eligible.
  • 4. Patient is willing and able to participate in a supervised home-based exercise program as determined by the MOVE program
  • a.Participants must have internet access and equipment to participate in virtual exercise
  • 5. ECOG performance status of 0-2
Exclusion Criteria
  • 1. Already meeting exercise guidelines and participating in at least 150 minutes of moderate or vigorous exercise per IPAQ
  • 2. Unable to participate in the supervised home-based exercise program as determined by the MOVE program
  • 3. Medical co-morbidities that preclude patient from participating in supervised exercise, including but not limited to
    • * Advanced heart failure
    • * Advanced respiratory disease requiring home oxygen use
    • * Uncontrolled psychiatric disorders
    • * History of fragility fracture
Exercise as Maintenance Therapy in Advanced Lung Cancer

Location Details

NCT06513663

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Indiana

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States, 46202

RECRUITING

United States, Indiana

Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States, 46202

RECRUITING

United States, Indiana

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States, 46202