Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a 12-week exercise program is practical and how it affects people with advanced lung cancer who are getting immunotherapy, a treatment that helps the immune system fight cancer. It compares short bursts of hard exercise, steady exercise at a medium effort, and usual care.
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)
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 or older.
- Have non-small cell lung cancer confirmed by a tissue test.
- Have received immunotherapy for at least 1 month, with plans to continue for at least 12 more weeks.
- Have your cancer doctor's approval for exercise and testing, with no uncontrolled health problems that exercise could worsen.
- Be able to communicate and fill out forms in English.
- Have done no more than 60 minutes per week of medium-to-hard aerobic exercise, such as brisk walking, over the past month.
- Be able to understand the study and willing to sign a consent form before any study procedures.
- Be willing to travel to DFCI for study data collection.
Who can't join
- Have done more than 60 minutes per week of medium-to-hard aerobic exercise over the past month.
- Have unstable health problems that make medium-to-hard exercise unsafe.
- The study doctor believes you may not be able to follow the study's safety checks.
- Have a second cancer that needs treatment at the same time and would interfere with this study. Basal cell and squamous cell skin cancers do not count.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
MA
- Dana-Farber Cancer Institute · Boston, MA 02215Christina Dieli-Conwright, PhD, MPH · Study contact · 617-582-8321 · christinam_dieli-conwright@dfci.harvard.eduChristina Dieli-Conwright, PhD, MPH · Principal investigatorMore trials in Boston