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

NCT06026111 | Recruiting

• 1 other identifier: 23-247
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

Conditions

Lung Cancer

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants completing the exercise intervention sessions

  The primary outcome is feasibility and will be assessed by the proportion of enrolled participants completing the exercise intervention sessions with \>/=70% completion considered feasible.

  Up to 14 weeks

Secondary Outcomes (9)

• Neutrophil-lymphocyte ratio (NLR)

  Baseline (Week 1) and post-intervention (Week 14)

• Cardiopulmonary Fitness

  Baseline (Week 1) and post-intervention (Week 14)

• Muscular Strength

  Baseline (Week 1) and post-intervention (Week 14)

• Short Physical Performance Battery

  Baseline (Week 1) and post-intervention (Week 14)

• Patient Reported Outcomes - Health-related quality of life

  Baseline (Week 1) and post-intervention (Week 14)

Study Arms (3)

High-Intensity Interval Training (HIIT)

EXPERIMENTAL

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.

Behavioral: High-Intensity Interval Training (HIIT)

Moderate-Intensity Continuous Training (MICT)

EXPERIMENTAL

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.

Behavioral: Moderate-Intensity Continuous Training (MICT)

Usual Care (UC)

NO INTERVENTION

Participants will be asked to maintain their baseline exercise behavior.

Interventions

High-Intensity Interval Training (HIIT) BEHAVIORAL

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

High-Intensity Interval Training (HIIT)

Moderate-Intensity Continuous Training (MICT) BEHAVIORAL

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

Moderate-Intensity Continuous Training (MICT)

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.
• Histologically diagnosed with 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christina Dieli-Conwright, PhD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Dieli-Conwright, PhD, MPH

CONTACT

617-582-8321; christinam_dieli-conwright@dfci.harvard.edu

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: Principle Investigator

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: September 6, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)