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Exercise Rehabilitation in Veteran Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03621813
Recruitment Status : Not yet recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Baltimore VA Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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 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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Exercise Rehabilitation Other: Control Not Applicable

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:

  1. To determine the feasibility of conducting an exercise rehabilitation intervention in Veterans with NSCLC and PTPP or CIPN.
  2. To determine the effects of a VAMHCS-supervised activity rehabilitation program on chronic pain, and sensory thresholds (thermal, static, and dynamic) compared to delayed control.
  3. To assess changes in fitness, strength, physical function, fatigue, and quality of life (QoL) after activity-based rehabilitation compared to control period.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Cancer survivors will be enrolled in a 6-week delayed entry control period followed by 6-week exercise rehabilitation program.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Progressive Activity-Based Rehabilitation in Veteran Cancer Survivors With Chronic Pain
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control
Participants maintain their current activity level.
Other: Control
Participants are instructed to maintain current activity level and are monitored for changes.

Active Comparator: Exercise Rehabilitation
Participants will exercise 2x/week at training facilities and at home one day a week.
Behavioral: Exercise Rehabilitation
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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 ]
    0-10 numeric rating

  2. Quantitative Sensory Testing Change [ Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention ]
    thermal, mechanical, and vibration sensation

  3. Fitness Change [ Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention ]
    VO2peak

  4. Strength Change [ Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention ]
    knee extensor strength



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 60-80 years
  2. Diagnosis with lung cancer, stage I-III
  3. History of treatment with either thoracotomy procedure or neurotoxic chemotherapy or both
  4. Completion of thoracotomy or chemotherapy > or = 6 months
  5. Ability to walk on a treadmill
  6. Karnofsky performance status > 70
  7. Score > 1 Neuropathic Pain Scale

Exclusion Criteria:

  1. Presence of metastatic (stage IV)
  2. Life expectancy < 6 months
  3. Musculoskeletal or medical conditions which preclude participation in an exercise program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621813


Contacts
Contact: Alice S Ryan, PhD (410) 605-7851 Alice.Ryan@va.gov
Contact: Lynda C Robey (410) 605-7000 ext 5446 lynda.robey@va.gov

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Alice S Ryan, PhD    410-605-7851    Alice.Ryan@va.gov   
Principal Investigator: Alice S. Ryan, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Baltimore VA Medical Center
Investigators
Principal Investigator: Alice S. Ryan, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03621813     History of Changes
Other Study ID Numbers: E2870-P
HP-00081388 ( Other Identifier: Baltimore VAMC )
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Neuropathic Pain
Exercise
Lung Cancer