Lung CancerENHANCENCT06026111
Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial
A study testing High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT) in people with Lung Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Christina Dieli-Conwright, PhD, MPH, 617-582-8321, christinam_dieli-conwright@dfci.harvard.edu
Christina Dieli-Conwright, PhD, MPH
About this study
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)
Read the detailed description
This single-center, three-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:
- 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. The UC group will be asked not to change their baseline exercise behavior and will be offered to receive one of the exercise programs at the end of the initial 12 weeks.
- Conditions
- Lung Cancer
- Being tested
- High-Intensity Interval Training (HIIT), Moderate-Intensity Continuous Training (MICT)
- Keywords
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval Training (HIIT)Behavioural
Home-based, virtually supervised, aerobic exercise intervention at a high intensity in an interval fashion.
Moderate-Intensity Continuous Training (MICT)Behavioural
Home-based, virtually supervised, aerobic exercise intervention at a moderate intensity in a continuous fashion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Moderate-Intensity Continuous Training (MICT) |
| Usual Care (UC) | No intervention | Participants will be asked to maintain their baseline exercise behavior. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 weeks
Secondary outcomes (9)
Neutrophil-lymphocyte ratio (NLR)
Neutrophil-lymphocyte ratio (NLR) will be assessed as a systemic immune marker as well as a prognostic marker of immunotherapy. Mononuclear lymphocyte phenotypes will be conducted in the Immune Assessment Laboratory. Immunofluorescence assays in whole blood will identify the counts of neutrophils and lymphocytes. Fasting blood will be taken in the morning following an overnight fast. Two 10.0 mL EDTA tubes will be collected and one spun for 10 minutes at 2860rpm within one hour of collection and 1.0mL of plasma will be transferred to a secondary tube to cryovials. Samples will be stored or shipped frozen at -70°C. Samples will be centrifuged, stored at -80°C, and batch-analyzed after post-intervention assessments.
Measured: Baseline (Week 1) and post-intervention (Week 14)
Cardiopulmonary Fitness
Cardiorespiratory fitness will be assessed as VO2peak by a graded maximal cycle exercise stress test. VO2peak is defined as the highest values of oxygen uptake averaged among every 15-second interval during the test. VO2peak will be reported in both relative (ml·kg-1·min-1) and absolute (L/min) terms.
Measured: Baseline (Week 1) and post-intervention (Week 14)
Muscular Strength
Muscular strength will be measured as 1-repetition maximum (RM) (i.e., the greatest resistance that can be moved through the full range of motion), which has been the standard for strength assessments. 1-RM values will be estimated from 10-RM using validated equations on 12 exercises including the ten exercises utilized in the prescription not performed on machines.
Measured: Baseline (Week 1) and post-intervention (Week 14)
Short Physical Performance Battery
Physical function will be assessed by the Short Physical Performance Battery (SPPB), which includes the following 3 lower extremity measures completed in the following order. Timed balance (seconds): Balance will be assessed under 3 conditions (side-by-side, semi-tandem, and tandem stands). Gait speed (seconds): Gait speed will be assessed over a 4-meter flat surface distance. The participant will be asked to complete 2 attempts of this test. Time will be recorded using an electronic timing system. Chair stand (seconds): Chair stand will be performed under 2 conditions: a) subjects will perform a single chair stand; b) subjects will be asked to perform 5 repeated chair stands as quickly as possible; time to completion will be recorded.
Measured: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Health-related quality of life
quality of life will be assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ)-C30.
Measured: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Lung-cancer related quality of life
Lung-cancer related quality of life will be assessed by the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Lung Cancer (EORTC-QLQ-LC)-29.
Measured: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Immunotherapy Symptoms
Immunotherapy symptoms will be assessed by the MD Anderson Symptom Inventory (MDASI) Immunotherapy early-phase trials (EPT).
Measured: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Anxiety and Depression
Anxiety and Depression will be assess using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, divided into two 7-item subscales (anxiety and depression). The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence) and the total score is out of 42 (21 per subscale).
Measured: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Sleep Quality
Sleep will be assessed using the Pittsburg Sleep Quality Index (PSQI).
Measured: Baseline (Week 1) and post-intervention (Week 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Feb 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
- Investigators
- Christina Dieli-Conwright, PhD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026111
- Sponsor's protocol ID
- 23-247
- Acronym
- ENHANCE
- Status last verified
- Oct 2026
- First submitted
- 10 Aug 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial
- ClinicalTrials.gov ID
- NCT06026111
- Acronym / sponsor ID
- ENHANCE / 23-247
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
This single-center, three-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:
- 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. The UC group will be asked not to change their baseline exercise behavior and will be offered to receive one of the exercise programs at the end of the initial 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training (HIIT) | Experimental | Behavioral: 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. |
| Moderate-Intensity Continuous Training (MICT) | Experimental | Behavioral: 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. |
| Usual Care (UC) | No intervention | –Participants will be asked to maintain their baseline exercise behavior. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Interval Training (HIIT)Home-based, virtually supervised, aerobic exercise intervention at a high intensity in an interval fashion. | Behavioural | High-Intensity Interval Training (HIIT) |
| Moderate-Intensity Continuous Training (MICT)Home-based, virtually supervised, aerobic exercise intervention at a moderate intensity in a continuous fashion. | Behavioural | Moderate-Intensity Continuous Training (MICT) |
Primary outcome
Proportion of Participants completing the exercise intervention sessions
Time frame: Up to 14 weeks
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.
9 secondary outcomes
Neutrophil-lymphocyte ratio (NLR)
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Cardiopulmonary Fitness
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Muscular Strength
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Short Physical Performance Battery
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Health-related quality of life
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Lung-cancer related quality of life
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Immunotherapy Symptoms
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Anxiety and Depression
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Patient Reported Outcomes - Sleep Quality
Time frame: Baseline (Week 1) and post-intervention (Week 14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Dieli-Conwright, PhD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT) in people with Lung Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Dieli-Conwright, PhD, MPH (617-582-8321, christinam_dieli-conwright@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants completing the exercise intervention sessions (time frame: Up to 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.