Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial

NCT ID: NCT06026111

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2027-12-31

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.

Conditions

Lung Cancer

Study Design

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

Study Groups

High-Intensity Interval Training (HIIT)

Patients in the HIIT group will perform alternating vigorous-intensity and recovery aerobic exercise intervals on a provided home stationary bike. The HIIT protocol consists of alternating a high-intensity exercise phase (1 min at 65-90% of workload corresponding to VO2peak) and a recovery phase (1 min at 30%), and the high-intensity and recovery intervals will be repeated 5-10 times in each session.

Group Type: EXPERIMENTAL

High-Intensity Interval Training (HIIT)

Intervention Type: BEHAVIORAL

Home-based, virtually supervised, aerobic exercise intervention at a high intensity in an interval fashion.

Moderate-Intensity Continuous Training (MICT)

The MICT group will perform an aerobic exercise at a continuous intensity in each session on a stationary bike. Similar to HIIT, the intensity will be progressed (47.5-60%). The total work of MICT is equalized with HIIT for training volume and frequency to compare the differences exerted from different intensities and energy expenditure.

Group Type: EXPERIMENTAL

Moderate-Intensity Continuous Training (MICT)

Intervention Type: BEHAVIORAL

Home-based, virtually supervised, aerobic exercise intervention at a moderate intensity in a continuous fashion.

Usual Care (UC)

Participants will be asked to maintain their baseline exercise behavior and will be offered to participate in the HIIT exercise program upon the completion of post-intervention assessments after the initial 12 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Moderate-Intensity Continuous Training (MICT)

Home-based, virtually supervised, aerobic exercise intervention at a moderate intensity in a continuous fashion.

Intervention Type: BEHAVIORAL

High-Intensity Interval Training (HIIT)

Home-based, virtually supervised, aerobic exercise intervention at a high intensity in an interval fashion.

Intervention Type: BEHAVIORAL

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.

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Christina Dieli-Conwright, PhD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina Dieli-Conwright, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christina Dieli-Conwright, PhD, MPH

Role: CONTACT

christinam_dieli-conwright@dfci.harvard.edu

617-582-8321

Facility Contacts

Christina Dieli-Conwright, PhD, MPH

Role: primary

christinam_dieli-conwright@dfci.harvard.edu

617-582-8321

Other Identifiers

23-247

Identifier Type: -

Identifier Source: org_study_id