Exercise program for patients with advanced lung cancer

Exercise as Maintenance Therapy in Advanced Lung Cancer

This study tests if a home-based exercise program can help people with advanced lung cancer feel less tired and improve their overall health and quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Indiana University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 3 sites (Indianapolis, Indiana and 2 other locations)
• Trial ID: NCT06513663 on ClinicalTrials.gov

What this trial studies

This study examines the effects of a supervised home-based exercise program on survival, function, and quality of life in patients with advanced lung cancer. Participants will be randomly assigned to either the exercise intervention or usual care for 12 weeks, with the exercise regimen administered virtually by trained professionals. The primary focus is to assess changes in patient-reported fatigue, while secondary objectives include evaluating improvements in cardiorespiratory fitness, physical function, and muscle mass.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with locally advanced or metastatic non-small cell lung cancer currently receiving maintenance immunotherapy.

Not a fit: Patients who are already meeting exercise guidelines or those currently undergoing chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the quality of life and potentially improve survival rates for patients with advanced lung cancer.

How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in cancer care, suggesting this approach may be beneficial.

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

Where this trial is running

Indianapolis, Indiana and 2 other locations

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

Study contacts

• Principal investigator: Tarah J Ballinger, MD — Indiana University
• Study coordinator: Malori Pojar

Conditions Lung Cancer; Non Small Cell Lung Cancer; Metastatic Lung Cancer; lung cancer; exercise; non small cell lung cancer