Nonsmall Cell Lung CancerNCT02949076
Skeletal Muscle Atrophy and Dysfunction in Human Cancer
A study testing Exercise in people with Nonsmall Cell Lung Cancer, run by University of Vermont at 1 site in United States.
Trial summary
Cancer and its treatment can have profound effects on skeletal muscle, the most well-recognized being atrophy, weakness and diminished oxidative capacity. These adaptations negatively impact quality of life, treatment decisions and survival. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Nonsmall Cell Lung Cancer
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jun 2023
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-75 yrs of age
- histologically-documented, stage III or IV non-small cell lung carcinoma (NSCLC)
- estimated life expectancy >6 mos
- Karnofsky's performance score of ≥70
Who cannot join
- history, signs or symptoms of inflammatory or autoimmune disease
- uncontrolled hypertension
- heart or renal failure
- exercise limitations from peripheral vascular disease or stroke
- neuromuscular disease
- knee/hip replacement
- additional, actively-treated malignancy or history of malignancy, except non-melanoma skin cancer
- taking medication that can have anti-coagulant effects that cannot be stopped prior to the muscle biopsy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont College of Medicine
Burlington, Vermont, 05405
About this study
Cancer and its treatment can have profound effects on skeletal muscle, the most well-recognized being atrophy, weakness and diminished oxidative capacity. These adaptations negatively impact quality of life, treatment decisions and survival. Despite these consequences, the factors promoting these adaptations remain poorly defined and understudied in human patients. To address this gap in knowledge, our goal in this study is to examine the role of muscle disuse as a regulator of muscle size and function in human cancer patients
- Conditions
- Nonsmall Cell Lung Cancer
- Being tested
- Exercise
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Unilateral lower limb resistance exercise will be performed 3 times per week for 8 weeks in non-small cell lung cancer patients on only one leg, while the contralateral leg serves as a non-exercising control.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Lung cancer patients will undergo unilateral resistance exercise 3 times per week for 8 weeks during cancer treatment, while the other leg remains unexercised and will serve as a within-subject control. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional area of skeletal muscle fibers
Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Measured: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Single muscle fiber contractile function
Segments of chemically-skinned single human muscle fibers will be assessed for cellular and molecular contractile parameters under maximal calcium-activated conditions, with muscle fiber type determined post-measurement by gel electrophoresis
Measured: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Mitochondrial content
Mitochondrial content will be assessed by electron microscopy.
Measured: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Mitochondrial function
Mitochondrial function will be assessed on isolated mitochondria
Measured: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Secondary outcomes (3)
Whole muscle size
Whole muscle size will be measured by computed tomography at the mid-thigh level.
Measured: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Whole muscle isometric function
Whole muscle volitional contractile function will be measured by isometric Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks by isometric dynamometry.
Measured: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Whole muscle isokinetic function
Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks by isokinetic dynamometry
Measured: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2023
- Study completionJun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina
- Responsible party
- Principal investigator, Michael J. Toth, Ph.D., University of Vermont
- Investigators
- Michael J. Toth, Ph.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949076
- Sponsor's protocol ID
- 16-506
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2016
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Research data (deidentified) which documents, supports and validates research findings will be stored on the University of Vermont College of Medicine computer system and will be made available upon final acceptance for publication of the major findings from the proposed studies. This includes raw data generated from all clinical and laboratory-based assessments under a data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Atrophy and Dysfunction in Human Cancer
- ClinicalTrials.gov ID
- NCT02949076
- Acronym / sponsor ID
- 16-506
- Conditions
- Nonsmall Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- University of South Carolina
- Study start
- Jul 2016
- Primary completion
- Jun 2023 (actual)
- Study completion
- Jun 2023 (actual)
- First posted
- 31 Oct 2016 (estimated)
- 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.
Cancer and its treatment can have profound effects on skeletal muscle, the most well-recognized being atrophy, weakness and diminished oxidative capacity. These adaptations negatively impact quality of life, treatment decisions and survival. Despite these consequences, the factors promoting these adaptations remain poorly defined and understudied in human patients. To address this gap in knowledge, our goal in this study is to examine the role of muscle disuse as a regulator of muscle size and function in human cancer patients
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseLung cancer patients will undergo unilateral resistance exercise 3 times per week for 8 weeks during cancer treatment, while the other leg remains unexercised and will serve as a within-subject control. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50-75 yrs of age
- histologically-documented, stage III or IV non-small cell lung carcinoma (NSCLC)
- estimated life expectancy >6 mos
- Karnofsky's performance score of ≥70
Key exclusion criteria (8 listed)
- history, signs or symptoms of inflammatory or autoimmune disease
- uncontrolled hypertension
- heart or renal failure
- exercise limitations from peripheral vascular disease or stroke
- neuromuscular disease
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 |
|---|---|---|
| ExerciseUnilateral lower limb resistance exercise will be performed 3 times per week for 8 weeks in non-small cell lung cancer patients on only one leg, while the contralateral leg serves as a non-exercising control. | Behavioural | Exercise |
Primary outcome
Cross-sectional area of skeletal muscle fibers
Time frame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Single muscle fiber contractile function
Time frame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Segments of chemically-skinned single human muscle fibers will be assessed for cellular and molecular contractile parameters under maximal calcium-activated conditions, with muscle fiber type determined post-measurement by gel electrophoresis
Mitochondrial content
Time frame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Mitochondrial content will be assessed by electron microscopy.
Mitochondrial function
Time frame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Mitochondrial function will be assessed on isolated mitochondria
3 secondary outcomes
Whole muscle size
Time frame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Whole muscle isometric function
Time frame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Whole muscle isokinetic function
Time frame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: Yes. Research data (deidentified) which documents, supports and validates research findings will be stored on the University of Vermont College of Medicine computer system and will be made available upon final acceptance for publication of the major findings from the proposed studies. This includes raw data generated from all clinical and laboratory-based assessments under a data-sharing agreement.
Related trials for Nonsmall Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Michael J. Toth, Ph.D. principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Nonsmall Cell Lung Cancer, run by University of Vermont 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 5 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cross-sectional area of skeletal muscle fibers (time frame: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks). The study lists 4 primary outcomes in all. 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 5 Dec 2023.