Clinical trial NCT06513663: Exercise as Maintenance Therapy in Advanced Lung Cancer
Official title: Exercise as Maintenance Therapy in Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Non Small Cell Lung Cancer
Metastatic Lung Cancer
Keywords: lung cancer
exercise
non small cell lung cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in patient-reported fatigue
timeFrame: baseline, week 12, and week 24
Secondary outcomes:
measure: Change in cardiorespiratory fitness
timeFrame: baseline, week 12, and week 24
measure: Change in physical performance battery
timeFrame: baseline, week 12, and week 24
measure: Change in muscle mass
timeFrame: baseline, and week 12
measure: Change in muscle density
timeFrame: baseline, and week 12
measure: Change in depression
timeFrame: baseline, week 12, and week 24
measure: Proportion of patients who are "fatigued"
timeFrame: baseline, week 12, and week 24
measure: Uptake of the study
timeFrame: date open to accrual until closed to accrual, up to 5 years
measure: Adherence with the intervention defined
timeFrame: baseline to post 12-week intervention
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin & Bren Simon Comprehensive Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Sidney and Lois Eskenazi Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Tarah J Ballinger, MD
role: PRINCIPAL_INVESTIGATOR
References: