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NCT Number: NCT03621813

Exercise Rehabilitation in Veteran Cancer Survivors

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Behavior Lung Diseases Lung Neoplasms Motor Activity Neoplasms Neoplasms by Site Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Exercise Rehabilitation

Behavioral

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.

Control

Other

Participants are instructed to maintain current activity level and are monitored for changes.

Primary outcomes

  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 outcomes

  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. Fitness Change

    Time frame: Measured at baseline, after 6 weeks control, and after 6 week intervention

    VO2peak

  3. Strength Change

    Time frame: Measured at baseline, after 6 weeks control, and after 6 week intervention

    knee extensor strength

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Baltimore VA Medical Center

Registry information

Official study title

Progressive Activity-Based Rehabilitation in Veteran Cancer Survivors With Chronic Pain

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2018
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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