Exercise Rehabilitation in Veteran Cancer Survivors

Not Applicable

Active, not recruiting

• Conditions: Cancer
• Interventions: Other: Control; Behavioral: Exercise Rehabilitation

• Registration Number: NCT03621813
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-08-03
• Study First Submitted QC: 2018-08-03
• Study First Posted: 2018-08-08
• Study Start: 2019-08-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-12-20
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control	Control	Participants maintain their current activity level.
Exercise Rehabilitation	Exercise Rehabilitation	Participants will exercise 2x/week at training facilities and at home one day a week.

Primary Outcome Measures

Name	Time	Method
Pain Visual Analog Scale Change	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

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

Trial Locations

Locations (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD; 🇺🇸 Baltimore, Maryland, United States