Exercise Rehabilitation in Veteran Cancer Survivors

NCT ID: NCT03621813

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-19
• Study Completion Date: 2026-12-30

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Participants maintain their current activity level.

Group Type: OTHER

Control

Intervention Type: OTHER

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

Exercise Rehabilitation

Participants will exercise 2x/week at training facilities and at home one day a week.

Group Type: ACTIVE_COMPARATOR

Exercise Rehabilitation

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Control

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baltimore VA Medical Center

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice S. Ryan, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00081388

Identifier Type: OTHER

Identifier Source: secondary_id

E2870-P

Identifier Type: -

Identifier Source: org_study_id