Exercise as Maintenance Therapy in Advanced Lung Cancer

NCT ID: NCT06513663

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2029-12-31

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.

Conditions

Lung Cancer; Non Small Cell Lung Cancer; Metastatic Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Tarah J Ballinger, MD

Assistant Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarah J Ballinger, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status: RECRUITING

Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Site Status: RECRUITING

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Malori Pojar

Role: CONTACT

mpojar@iu.edu

(317) 274-0930

Tarah J Ballinger, MD

Role: CONTACT

tarahb@iu.edu

Facility Contacts

Malori Pojar

Role: primary

mpojar@iu.edu

(317) 274-0930

Malori Pojar

Role: primary

mpojar@iu.edu

(317) 274-0930

Malori Pojar

Role: primary

mpojar@iu.edu

(317) 274-0930

Other Identifiers

CTO-IUSCCC-0865

Identifier Type: -

Identifier Source: org_study_id