Clinical trial NCT06026111: Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial
Official title: Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-09-06
Enrollment: 30
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 the feasibility and effects of 12-week exercise training at different intensities among individuals with advanced lung cancer receiving immune checkpoint inhibitors.

The names of the study interventions involved in this study are:

Detailed description: This single-center, two-armed, pilot randomized controlled research study will assess feasibility and compare immune activities, cardiorespiratory fitness, physical function, and immunotherapy-related adverse events, and patient-reported outcomes between three groups - high-intensity exercise, moderate-intensity exercise, and usual care.

Participants in this study will be randomly assigned to one of three groups:

* High-intensity interval training (HIIT)
* Moderate-intensity continuous training (MICT)
* Usual care (UC) The HIIT and the MICT groups will receive virtually supervised home-based exercise training three sessions per week for 12 weeks. The UC group will be asked not to change their baseline exercise behavior and will be offered to receive one of the exercise programs at the end of the initial 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years.
* Histologically diagnosed with advanced non-small cell lung cancer (NSCLC).
* Having been receiving anti-PD-1 or anti-PD-L1 antibodies (i.e., single agent or combination) for at least one month with a plan to continue for at least 12 weeks prospectively at the time of recruitment.
* Medical clearance to perform exercise intervention and testing by their treating oncologist.
* No uncontrolled medical conditions that could be exacerbated with exercise (e.g., uncontrolled hypertension or diabetes).
* Ability to communicate and complete written forms in English.
* Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month.
* Ability to understand and the willingness to sign informed consent prior to any study-related procedures.
* Willing to travel to DFCI for necessary data collection.

Exclusion Criteria:

* Participate in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention outcomes.
* Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because part of this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded.
* Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
* Development of second malignancy (except for basal cell carcinoma or squamous cell carcinoma of the skin) that requires concurrent treatment, which would interfere with this study.

Primary outcomes:
measure: Proportion of Participants completing the exercise intervention sessions
timeFrame: Up to 14 weeks
Secondary outcomes:
measure: Neutrophil-lymphocyte ratio (NLR)
timeFrame: Baseline (Week 1) and post-intervention (Week 14)
measure: Cardiopulmonary Fitness
timeFrame: Baseline (Week 1) and post-intervention (Week 14)
measure: Muscular Strength
timeFrame: Baseline (Week 1) and post-intervention (Week 14)
measure: Short Physical Performance Battery
timeFrame: Baseline (Week 1) and post-intervention (Week 14)
measure: Patient Reported Outcomes - Health-related quality of life
timeFrame: Baseline (Week 1) and post-intervention (Week 14)
measure: Patient Reported Outcomes - Lung-cancer related quality of life
timeFrame: Baseline (Week 1) and post-intervention (Week 14)
measure: Patient Reported Outcomes - Immunotherapy Symptoms
timeFrame: Baseline (Week 1) and post-intervention (Week 14)
measure: Patient Reported Outcomes - Anxiety and Depression
timeFrame: Baseline (Week 1) and post-intervention (Week 14)
measure: Patient Reported Outcomes - Sleep Quality
timeFrame: Baseline (Week 1) and post-intervention (Week 14)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christina Dieli-Conwright, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: