Examining exercise training effects during immunotherapy in lung cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized controlled trial investigates the feasibility and effects of a 12-week exercise training program at varying intensities for patients with advanced lung cancer undergoing immune checkpoint inhibitor therapy. Participants will be randomly assigned to one of three groups: high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or usual care. The study aims to compare immune activities, cardiorespiratory fitness, physical function, immunotherapy-related adverse events, and patient-reported outcomes among the groups. The exercise interventions will be conducted virtually, with participants engaging in three sessions per week for the duration of the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years.
* Histologically diagnosed with non-small cell lung cancer (NSCLC).
* Receiving or scheduled to begin immunotherapy, as monotherapy or in combination, in the neoadjuvant, adjuvant, or metastatic/advanced setting, with a plan to continue immunotherapy throughout the exercise intervention period (for neoadjuvant patients, throughout the planned preoperative immunotherapy course prior to surgery).
* 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 main campus 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.

Where it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Christina Dieli-Conwright, PhD, MPH — Dana-Farber Cancer Institute
• Study coordinator: Christina Dieli-Conwright, PhD, MPH
• Email: christinam_dieli-conwright@dfci.harvard.edu
• Phone: 617-582-8321

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.