Lung Cancer Clinical Trial
Feasibility and Preliminary Efficacy of Exercise During Immunotherapy in Patients With Lung Cancer: The INHALE Trial
The purpose of this study is to determine whether a 12-week, home-based, virtually supervised exercise intervention is feasible and improves various health outcomes among individuals with advanced lung cancer receiving immunotherapy.
The names of the study interventions involved in this study are:
High-intensity interval training (HIIT) (Home-based, virtually supervised, high intensity training in an interval fashion)
Moderate-intensity continuous training (MICT) (Home-based, virtually supervised, moderate intensity in a continuous fashion)
Usual care (UC)
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: Group A High-intensity interval training (HIIT), Group B Moderate-intensity continuous training (MICT), or Group C Usual Care (UC). The HIIT and the MICT groups will receive virtually (Zoom) supervised home-based exercise training three sessions per week for 12 weeks. Randomization means that a participant is placed into a study group by chance.
The research study procedures include screening for eligibility and study treatment including extensive evaluations of fitness and physical health, blood tests, and questionnaires/surveys.
Participation in this research study is expected to last for up to 12 weeks.
It is expected that about 30 people will take part in this research study.
Age ≥18 years; due to the rarity of the disease in those <18 years, this age bracket will not be included.
Histologically diagnosed with metastatic Non-small cell lung cancer (NSCLC).
Having been receiving single-agent anti-PD-1 or anti-PD-L1 monoclonal antibodies for at least one month (e.g., pembrolizumab, nivolumab, atezolizumab, durvalumab, cemiplimab, and avelumab) with a plan to continue for at least 12 weeks prospectively at the time of recruitment.
Not receiving other concurrent systemic treatment (e.g., chemotherapy or targeted therapy).
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.
Receiving other concurrent systemic treatment for NSCLC such as chemotherapy or targeted therapy. This study is to exclusively target patients receiving anti-PD-1/PD-L-1 where other treatments may impact the study outcomes of intervention feasibility and efficacies.
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.
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