CancerNCT03621813
Exercise Rehabilitation in Veteran Cancer Survivors
A study testing Exercise Rehabilitation in people with Cancer, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Exercise rehabilitation has the potential as a non-pharmacological approach to reduce persistent neuropathic pain in Veterans with lung cancer. By examining the effects of exercise training in Veteran cancer survivors with NSCLC, there is the potential to revolutionize care for a: common, debilitating, and… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- Exercise Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to 30 Dec 2026
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60-80 years
- Diagnosis with lung cancer
- History of treatment with either thoracotomy procedure or neurotoxic chemotherapy or both
- Completion of thoracotomy or chemotherapy > or = 6 months
- Ability to walk on a treadmill
- Karnofsky performance status > 70
- Score > 1 Neuropathic Pain Scale
Who cannot join
- Presence of metastatic (stage IV)
- Life expectancy < 6 months
- Musculoskeletal or medical conditions which preclude participation in an exercise program
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Official title: Progressive Activity-Based Rehabilitation in Veteran Cancer Survivors With Chronic Pain
Exercise rehabilitation has the potential as a non-pharmacological approach to reduce persistent neuropathic pain in Veterans with lung cancer. By examining the effects of exercise training in Veteran cancer survivors with NSCLC, there is the potential to revolutionize care for a: common, debilitating, and inadequately treated symptom in a growing population. This could lead to a larger investigation to fill critical gaps in the literature and at the same time help discover a new model of care for Veterans with chronic pain. The ultimate goal is to reduce this type of pain for the growing population of cancer survivors while simultaneously reducing the need for problematic opioid management.
Read the detailed description
Persistent or chronic neuropathic pain, either post-thoracotomy persistent pain (PTPP) or chemotherapy-induced peripheral neuropathy (CIPN) occurs in a majority of lung cancer patients. Thus, not only is this neuropathic pain widespread; there is no way to prevent its development, and long-term use of opioids for control of symptoms could result in addiction. Ultimately, PTPP and CIPN can lead to long-term suffering and disability during the post-treatment phase.(NSCLC), which represents about 85% of lung cancer cases.This is the first project of its kind and the potential impact of this research is large, because exercise training will be a prescription and the first approach for which NSCLC survivors can self-manage chronic neuropathic pain. The ultimate goal of the investigators' work is to reduce neuropathic pain for the growing population of cancer survivors while simultaneously reducing the need for problematic pharmacologic management. Therefore, results of this study have potential for high impact on symptom care because it will allow effective neuropathic pain treatment to be in full control of the Veteran, and likely restore function that is lost during the chronic pain experience.
Specific Aims:
- To determine the feasibility of conducting an exercise rehabilitation intervention in Veterans with NSCLC and PTPP or CIPN.
- To determine the effects of a VAMHCS-supervised activity rehabilitation program on chronic pain compared to delayed control.
- To assess changes in fitness, strength, physical function, fatigue, and quality of life (QoL) after activity-based rehabilitation compared to control period.
- Conditions
- Cancer
- Being tested
- Exercise Rehabilitation, Control
- Keywords
- Neuropathic Pain, Exercise, Lung Cancer
- Medical subject headings
- Neoplasms, Neuralgia, Motor Activity, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise RehabilitationBehavioural
This training is designed to improve fitness, target the major muscle groups for strength, and to improve balance. Aerobic exercise of walking on a treadmill will be performed. Thera-Bands will be used for resistance exercise for the lower and upper body. Balance program includes core exercises (stepping, weight shifts, etc.) and other progressive exercises.
ControlOther
Participants are instructed to maintain current activity level and are monitored for changes.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Participants maintain their current activity level. Receives: Other: Control |
| Exercise Rehabilitation | Active comparator | Participants will exercise 2x/week at training facilities and at home one day a week. Receives: Behavioral: Exercise Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analog Scale Change
Scale of 0 (no pain) to 100 (worst imaginable pain)
Measured: Measured at baseline, after 6 weeks control, and after 6 week intervention
Secondary outcomes (3)
Patient-Reported Outcomes Measurement System Neuropathic Pain Quality (PROMIS-PQ Neuro) Change
0-10 numeric rating
Measured: Measured at baseline, after 6 weeks control, and after 6 week intervention
Fitness Change
VO2peak
Measured: Measured at baseline, after 6 weeks control, and after 6 week intervention
Strength Change
knee extensor strength
Measured: Measured at baseline, after 6 weeks control, and after 6 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start19 Aug 2019
- Primary completion20 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Cancer survivors will be enrolled in a 6-week delayed entry control period followed by 6-week exercise rehabilitation program.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Baltimore VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Alice S. Ryan, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621813
- Sponsor's protocol ID
- E2870-P
- Other IDs
- HP-00081388
- Status last verified
- Feb 2026
- First submitted
- 3 Aug 2018
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Activity-Based Rehabilitation in Veteran Cancer Survivors With Chronic Pain
- ClinicalTrials.gov ID
- NCT03621813
- Acronym / sponsor ID
- E2870-P
- Conditions
- Cancer
- Keywords
- Neuropathic Pain, Exercise, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Baltimore VA Medical Center
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Aug 2018 (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.
Exercise rehabilitation has the potential as a non-pharmacological approach to reduce persistent neuropathic pain in Veterans with lung cancer. By examining the effects of exercise training in Veteran cancer survivors with NSCLC, there is the potential to revolutionize care for a: common, debilitating, and inadequately treated symptom in a growing population. This could lead to a larger investigation to fill critical gaps in the literature and at the same time help discover a new model of care for Veterans with chronic pain. The ultimate goal is to reduce this type of pain for the growing population of cancer survivors while simultaneously reducing the need for problematic opioid management.
Detailed description
Persistent or chronic neuropathic pain, either post-thoracotomy persistent pain (PTPP) or chemotherapy-induced peripheral neuropathy (CIPN) occurs in a majority of lung cancer patients. Thus, not only is this neuropathic pain widespread; there is no way to prevent its development, and long-term use of opioids for control of symptoms could result in addiction. Ultimately, PTPP and CIPN can lead to long-term suffering and disability during the post-treatment phase.(NSCLC), which represents about 85% of lung cancer cases.This is the first project of its kind and the potential impact of this research is large, because exercise training will be a prescription and the first approach for which NSCLC survivors can self-manage chronic neuropathic pain. The ultimate goal of the investigators' work is to reduce neuropathic pain for the growing population of cancer survivors while simultaneously reducing the need for problematic pharmacologic management. Therefore, results of this study have potential for high impact on symptom care because it will allow effective neuropathic pain treatment to be in full control of the Veteran, and likely restore function that is lost during the chronic pain experience.
Specific Aims:
- To determine the feasibility of conducting an exercise rehabilitation intervention in Veterans with NSCLC and PTPP or CIPN.
- To determine the effects of a VAMHCS-supervised activity rehabilitation program on chronic pain compared to delayed control.
- To assess changes in fitness, strength, physical function, fatigue, and quality of life (QoL) after activity-based rehabilitation compared to control period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cancer survivors will be enrolled in a 6-week delayed entry control period followed by 6-week exercise rehabilitation program.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ControlParticipants maintain their current activity level. |
| Exercise Rehabilitation | Active comparator | Behavioral: Exercise RehabilitationParticipants will exercise 2x/week at training facilities and at home one day a week. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 60-80 years
- Diagnosis with lung cancer
- History of treatment with either thoracotomy procedure or neurotoxic chemotherapy or both
- Completion of thoracotomy or chemotherapy > or = 6 months
- Ability to walk on a treadmill
Key exclusion criteria (3 listed)
- Presence of metastatic (stage IV)
- Life expectancy < 6 months
- Musculoskeletal or medical conditions which preclude participation in an exercise program
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 RehabilitationThis training is designed to improve fitness, target the major muscle groups for strength, and to improve balance. Aerobic exercise of walking on a treadmill will be performed. Thera-Bands will be used for resistance exercise for the lower and upper body. Balance program includes core exercises (stepping, weight shifts, etc.) and other progressive exercises. | Behavioural | Exercise Rehabilitation |
| ControlParticipants are instructed to maintain current activity level and are monitored for changes. | Other | Control |
Primary outcome
Pain Visual Analog Scale Change
Time frame: Measured at baseline, after 6 weeks control, and after 6 week intervention
Scale of 0 (no pain) to 100 (worst imaginable pain)
3 secondary outcomes
Patient-Reported Outcomes Measurement System Neuropathic Pain Quality (PROMIS-PQ Neuro) Change
Time frame: Measured at baseline, after 6 weeks control, and after 6 week intervention
Fitness Change
Time frame: Measured at baseline, after 6 weeks control, and after 6 week intervention
Strength Change
Time frame: Measured at baseline, after 6 weeks control, and after 6 week intervention
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 14 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Alice S. Ryan, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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 Rehabilitation in people with Cancer, run by VA Office of Research and Development 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 14 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?
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?
Pain Visual Analog Scale Change (time frame: Measured at baseline, after 6 weeks control, and after 6 week intervention). 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 14 Oct 2026.