Exercise as Maintenance Therapy in Advanced Lung Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer; Non Small Cell Lung Cancer; Metastatic Lung Cancer
• Intervention / Treatment: Behavioral: Exercise Intervention

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
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Methodist Hospital
    • Indianapolis, Indiana, United States, 46202
      • Sidney and Lois Eskenazi Hospital
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Usual Care; Participants randomized to usual care arm will receive care per their treatment team. Usual care participants are encouraged to exercise but will not be provided components of the intervention. Participants in the usual care arm will be given usual care handouts at baseline.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Tarah J Ballinger, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): June 4, 2025
• Study Completion (Actual): June 4, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: exercise; lung cancer; non small cell lung cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Behavior; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Motor Activity
• Other Study ID Numbers: CTO-IUSCCC-0865

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No