Exercise as Maintenance Therapy in Advanced Lung Cancer

Not Applicable

Recruiting

• Conditions: Non Small Cell Lung Cancer; Metastatic Lung Cancer; Lung Cancer
• Interventions: Behavioral: Exercise Intervention

• Registration Number: NCT06513663
• Lead Sponsor: Indiana University

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.

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 Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-22
• Study Start: 2024-10-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Intervention	Exercise Intervention	Eligible and consented participants randomized to the exercise arm will work with an exercise trainer three times weekly for 12 weeks. Training sessions will be delivered virtually using HIPPA Complaint IU Health Zoom. These sessions will last 60 minutes and include cardiovascular exercise, resistance training, and balance or stretching exercise. The participants will be able to use any equipment they already have at home but will be provided a heart monitor and a set of resistance bands. All sessions will have a moderate-intensity training goal, defined as 40-80% of heart rate reserve (HRR). Cardiovascular exercise will include any at-home equipment available to the participants or follow a Tabata-style program. Resistance training will include a full body workout, emphasizing all major muscle groups. Trainers will progress or regress intensity levels based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session.

Primary Outcome Measures

Name	Time	Method
Change in patient-reported fatigue	baseline, week 12, and week 24	Measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) survey

Secondary Outcome Measures

Name	Time	Method
Change in muscle mass	baseline, and week 12	measured by mg/kg2 on HU on CT scans
Adherence with the intervention defined	baseline to post 12-week intervention	the proportion of scheduled sessions attended by participants randomized to the exercise intervention arm
Change in cardiorespiratory fitness	baseline, week 12, and week 24	Measured by VO2peak, estimated as time on the treadmill
Change in physical performance battery	baseline, week 12, and week 24	total score on short physical performance battery
Change in muscle density	baseline, and week 12	measured by mg/kg2 on HU on CT scans
Change in depression	baseline, week 12, and week 24	measured by total score of HADS survey
Proportion of patients who are "fatigued"	baseline, week 12, and week 24	measured by FACT-F score of \<43
Uptake of the study	date open to accrual until closed to accrual, up to 5 years	the proportion of total patients approached, screened, and ultimately completing the baseline assessments

Trial Locations

Locations (3)

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Melvin & Bren Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Sidney and Lois Eskenazi Hospital; 🇺🇸 Indianapolis, Indiana, United States