Exercise Rehabilitation in Veteran Cancer Survivors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Control; Behavioral: Exercise Rehabilitation

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 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
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 60-80 years
2. Diagnosis with lung cancer
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Visual Analog Scale Change	Scale of 0 (no pain) to 100 (worst imaginable pain)	Measured at baseline, after 6 weeks control, and after 6 week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes Measurement System Neuropathic Pain Quality (PROMIS-PQ Neuro) Change	0-10 numeric rating	Measured at baseline, after 6 weeks control, and after 6 week intervention
Fitness Change	VO2peak	Measured at baseline, after 6 weeks control, and after 6 week intervention
Strength Change	knee extensor strength	Measured at baseline, after 6 weeks control, and after 6 week intervention

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Baltimore VA Medical Center
• Investigators: Principal Investigator: Alice S. Ryan, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 3, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Lung Cancer; Neuropathic Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neoplasms by Site; Neuromuscular Diseases; Respiratory Tract Diseases; Peripheral Nervous System Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Neoplasms; Lung Neoplasms; Neuralgia; Motor Activity; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Exercise Therapy
• Other Study ID Numbers: E2870-P; HP-00081388 (Other Identifier: Baltimore VAMC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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