Recruiting

Exercise Training

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06026111

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High-Intensity Interval Training (HIIT)

Moderate-Intensity Continuous Training (MICT)

Study Details

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:

  • High-intensity interval training (HIIT)
  • Moderate-intensity continuous training (MICT)
  • Usual care (UC)

Conditions

Lung Cancer

Study ID

NCT06026111

Start date

Feb 1, 2024

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years.
  • Histologically diagnosed with non-small cell lung cancer (NSCLC).
  • Having been receiving immunotherapy 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

no intervention: Usual Care (UC)

Participants will be asked to maintain their baseline exercise behavior.

Interventions

High-Intensity Interval Training (HIIT)

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

Moderate-Intensity Continuous Training (MICT)

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

Primary outcome measure

  • Proportion of Participants completing the exercise intervention sessions [ Time Frame: Up to 14 weeks ]

Central Contacts and Locations

Central contacts

Christina Dieli-Conwright, PhD, MPH

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

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christina Dieli-Conwright, PhD, MPH

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

Principal Investigator:

Christina Dieli-Conwright, PhD, MPH

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Aug 10, 2026

Last verified

Jul, 2026

Keywords

  • Lung Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-08-10.