Exercise as Maintenance Therapy in Advanced Lung Cancer

NCT06513663 | Terminated DMC

• 1 other identifier: CTO-IUSCCC-0865
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

lung cancer; exercise; non small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Change in patient-reported fatigue

  Measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) survey

  baseline, week 12, and week 24

Secondary Outcomes (8)

• Change in cardiorespiratory fitness

  baseline, week 12, and week 24

• Change in physical performance battery

  baseline, week 12, and week 24

• Change in muscle mass

  baseline, and week 12

• Change in muscle density

  baseline, and week 12

• Change in depression

  baseline, week 12, and week 24

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Exercise Intervention 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.

Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Known diagnosis of locally advanced (stage III) or metastatic NSCLC
• Patient is currently receiving maintenance immunotherapy for at least 1 month and planned for at least 3 additional months of therapy
• 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
• 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.
• 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
• ECOG performance status of 0-2

You may not qualify if:

• Already meeting exercise guidelines and participating in at least 150 minutes of moderate or vigorous exercise per IPAQ
• Unable to participate in the supervised home-based exercise program as determined by the MOVE program
• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (3)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Melvin & Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Behavior

Study Officials

• Tarah J Ballinger, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: October 15, 2024
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (3)