Lung CancerNCT06513663
Exercise as Maintenance Therapy in Advanced Lung Cancer
A study testing Exercise Intervention in people with Lung Cancer and Non Small Cell Lung Cancer, run by Indiana University at 3 sites in United States.
Trial summary
The purpose of this study is to examine how a multimodality (having or using a variety of methods to do something) exercise intervention may improve survival, function, and quality of life in participants with advanced lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non Small Cell Lung Cancer, Metastatic Lung Cancer
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Oct 2024to 4 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Known diagnosis of locally advanced (stage III) or metastatic NSCLC
- Patient is currently receiving maintenance immunotherapy for at least 1 month and planned for at least 3 additional months of therapy
- Patients receiving maintenance therapy refers to patients with stable disease or partial response to therapy, including patients who have had a history of disease progression but are currently stable or responding to a different therapy
- Patients previously receiving chemotherapy are eligible as long as at least one month has elapsed since completing chemotherapy. Those currently receiving chemotherapy are not eligible.
- Patient is willing and able to participate in a supervised home-based exercise program as determined by the MOVE program
- a.Participants must have internet access and equipment to participate in virtual exercise
- ECOG performance status of 0-2
Who cannot join
- Already meeting exercise guidelines and participating in at least 150 minutes of moderate or vigorous exercise per IPAQ
- Unable to participate in the supervised home-based exercise program as determined by the MOVE program
- Medical co-morbidities that preclude patient from participating in supervised exercise, including but not limited to:
- Advanced heart failure
- Advanced respiratory disease requiring home oxygen use
- Uncontrolled psychiatric disorders
- History of fragility fracture
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
Indiana University Melvin & Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to examine how a multimodality (having or using a variety of methods to do something) exercise intervention may improve survival, function, and quality of life in participants with advanced lung cancer.
Read the detailed description
This study is a randomized control trial at a single institution comparing advanced lung cancer patients undergoing supervised home-based exercise program versus usual care. The intervention is a supervised home-based exercise program that will be coordinated by the MOVE program. The regimen will be 12 weeks in duration, three times a week, and administered by a trained professional virtually.
Participants will be randomized 1:1 to the exercise or usual care arm. Participants will be stratified on baseline frailty by the SPPB.
Primary Objective To compare changes patient-reported fatigue (by FACT-F survey) from baseline to post-intervention in patients with locally advanced and advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
Secondary Objectives
- To compare changes in cardiorespiratory fitness measured by VO2peak, estimated as time on the treadmill during ramp treadmill test, from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
- To compare changes in physical function measured by the short physical performance battery from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
- To compare changes in muscle mass and muscle density measured on CT scans for disease monitoring and bioimpedance analysis from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
- To compare changes in depression scores by HADS survey from baseline to post-intervention in patients with locally advanced and/or advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
- To compare the proportion of patients who are "fatigued," defined as a FACT-F score of <43 at post-intervention between the exercise and usual care arms.
- To evaluate uptake and adherence of supervised home-based exercise program in patients with locally advanced and/or advanced lung cancer receiving maintenance immunotherapy or targeted therapy, measured by the percentage of patients who consented to the study and percentage of training sessions attended by patients in the exercise arm.
- Being tested
- Exercise Intervention
- Keywords
- lung cancer, exercise, non small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Eligible and consented participants randomized to the exercise arm will work with an exercise trainer three times weekly for 12 weeks. Training sessions will be delivered virtually using HIPPA Complaint IU Health Zoom. These sessions will last 60 minutes and include cardiovascular exercise, resistance training, and balance or stretching exercise. The participants will be able to use any equipment they already have at home but will be provided a heart monitor and a set of resistance bands.
All sessions will have a moderate-intensity training goal, defined as 40-80% of heart rate reserve (HRR). Cardiovascular exercise will include any at-home equipment available to the participants or follow a Tabata-style program. Resistance training will include a full body workout, emphasizing all major muscle groups. Trainers will progress or regress intensity levels based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Eligible and consented participants randomized to the exercise arm will work with an exercise trainer three times weekly for 12 weeks. Training sessions will be delivered virtually using HIPPA Complaint IU Health Zoom. These sessions will last 60 minutes and include cardiovascular exercise, resistance training, and balance or stretching exercise. The participants will be able to use any equipment they already have at home but will be provided a heart monitor and a set of resistance bands.
All sessions will have a moderate-intensity training goal, defined as 40-80% of heart rate reserve (HRR). Cardiovascular exercise will include any at-home equipment available to the participants or follow a Tabata-style program. Resistance training will include a full body workout, emphasizing all major muscle groups. Trainers will progress or regress intensity levels based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session. Receives: Behavioral: Exercise Intervention |
| Usual Care | No intervention | Participants randomized to usual care arm will receive care per their treatment team. Usual care participants are encouraged to exercise but will not be provided components of the intervention. Participants in the usual care arm will be given usual care handouts at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-reported fatigue
Measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) survey
Measured: baseline, week 12, and week 24
Secondary outcomes (8)
Change in cardiorespiratory fitness
Measured by VO2peak, estimated as time on the treadmill
Measured: baseline, week 12, and week 24
Change in physical performance battery
total score on short physical performance battery
Measured: baseline, week 12, and week 24
Change in muscle mass
measured by mg/kg2 on HU on CT scans
Measured: baseline, and week 12
Change in muscle density
measured by mg/kg2 on HU on CT scans
Measured: baseline, and week 12
Change in depression
measured by total score of HADS survey
Measured: baseline, week 12, and week 24
Proportion of patients who are "fatigued"
measured by FACT-F score of <43
Measured: baseline, week 12, and week 24
Uptake of the study
the proportion of total patients approached, screened, and ultimately completing the baseline assessments
Measured: date open to accrual until closed to accrual, up to 5 years
Adherence with the intervention defined
the proportion of scheduled sessions attended by participants randomized to the exercise intervention arm
Measured: baseline to post 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start15 Oct 2024
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Why it stopped: trial stopped due to low accrual
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 Indiana UniversityThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarah J Ballinger, MD, Indiana University
- Investigators
- Tarah J Ballinger, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513663
- Sponsor's protocol ID
- CTO-IUSCCC-0865
- Status last verified
- Apr 2026
- First submitted
- 16 Jul 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise as Maintenance Therapy in Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT06513663
- Acronym / sponsor ID
- CTO-IUSCCC-0865
- Keywords
- lung cancer, exercise, non small cell lung cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: trial stopped due to low accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 22 Jul 2024 (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 how a multimodality (having or using a variety of methods to do something) exercise intervention may improve survival, function, and quality of life in participants with advanced lung cancer.
Detailed description
This study is a randomized control trial at a single institution comparing advanced lung cancer patients undergoing supervised home-based exercise program versus usual care. The intervention is a supervised home-based exercise program that will be coordinated by the MOVE program. The regimen will be 12 weeks in duration, three times a week, and administered by a trained professional virtually.
Participants will be randomized 1:1 to the exercise or usual care arm. Participants will be stratified on baseline frailty by the SPPB.
Primary Objective To compare changes patient-reported fatigue (by FACT-F survey) from baseline to post-intervention in patients with locally advanced and advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
Secondary Objectives
- To compare changes in cardiorespiratory fitness measured by VO2peak, estimated as time on the treadmill during ramp treadmill test, from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
- To compare changes in physical function measured by the short physical performance battery from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
- To compare changes in muscle mass and muscle density measured on CT scans for disease monitoring and bioimpedance analysis from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
- To compare changes in depression scores by HADS survey from baseline to post-intervention in patients with locally advanced and/or advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
- To compare the proportion of patients who are "fatigued," defined as a FACT-F score of <43 at post-intervention between the exercise and usual care arms.
- To evaluate uptake and adherence of supervised home-based exercise program in patients with locally advanced and/or advanced lung cancer receiving maintenance immunotherapy or targeted therapy, measured by the percentage of patients who consented to the study and percentage of training sessions attended by patients in the exercise arm.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Exercise InterventionEligible and consented participants randomized to the exercise arm will work with an exercise trainer three times weekly for 12 weeks. Training sessions will be delivered virtually using HIPPA Complaint IU Health Zoom. These sessions will last 60 minutes and include cardiovascular exercise, resistance training, and balance or stretching exercise. The participants will be able to use any equipment they already have at home but will be provided a heart monitor and a set of resistance bands. All sessions will have a moderate-intensity training goal, defined as 40-80% of heart rate reserve (HRR). Cardiovascular exercise will include any at-home equipment available to the participants or follow a Tabata-style program. Resistance training will include a full body workout, emphasizing all major muscle groups. Trainers will progress or regress intensity levels based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session. |
| Usual Care | No intervention | –Participants randomized to usual care arm will receive care per their treatment team. Usual care participants are encouraged to exercise but will not be provided components of the intervention. Participants in the usual care arm will be given usual care handouts at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Known diagnosis of locally advanced (stage III) or metastatic NSCLC
- Patient is currently receiving maintenance immunotherapy for at least 1 month and planned for at least 3 additional months of therapy
- Patient is willing and able to participate in a supervised home-based exercise program as determined by the MOVE program
- a.Participants must have internet access and equipment to participate in virtual exercise
Key exclusion criteria (7 listed)
- Already meeting exercise guidelines and participating in at least 150 minutes of moderate or vigorous exercise per IPAQ
- Unable to participate in the supervised home-based exercise program as determined by the MOVE program
- Medical co-morbidities that preclude patient from participating in supervised exercise, including but not limited to:
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 |
|---|---|---|
| Exercise InterventionEligible and consented participants randomized to the exercise arm will work with an exercise trainer three times weekly for 12 weeks. Training sessions will be delivered virtually using HIPPA Complaint IU Health Zoom. These sessions will last 60 minutes and include cardiovascular exercise, resistance training, and balance or stretching exercise. The participants will be able to use any equipment they already have at home but will be provided a heart monitor and a set of resistance bands. All sessions will have a moderate-intensity training goal, defined as 40-80% of heart rate reserve (HRR). Cardiovascular exercise will include any at-home equipment available to the participants or follow a Tabata-style program. Resistance training will include a full body workout, emphasizing all major muscle groups. Trainers will progress or regress intensity levels based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session. | Behavioural | Exercise Intervention |
Primary outcome
Change in patient-reported fatigue
Time frame: baseline, week 12, and week 24
Measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) survey
8 secondary outcomes
Change in cardiorespiratory fitness
Time frame: baseline, week 12, and week 24
Change in physical performance battery
Time frame: baseline, week 12, and week 24
Change in muscle mass
Time frame: baseline, and week 12
Change in muscle density
Time frame: baseline, and week 12
Change in depression
Time frame: baseline, week 12, and week 24
Proportion of patients who are "fatigued"
Time frame: baseline, week 12, and week 24
Uptake of the study
Time frame: date open to accrual until closed to accrual, up to 5 years
Adherence with the intervention defined
Time frame: baseline to post 12-week intervention
Results and safety
The study was stopped early (reason given: trial stopped due to low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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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. This study is not recruiting at the moment.
Tarah J Ballinger, MD principal investigator
Indiana University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Lung Cancer and Non Small Cell Lung Cancer, run by Indiana University at 3 sites 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study was stopped early (reason given: trial stopped due to low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-reported fatigue (time frame: baseline, week 12, and week 24). 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 27 Apr 2026.