Exercise Rehabilitation in Veteran Cancer Survivors

December 13, 2023 updated by: VA Office of Research and Development

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
        • Contact:
        • Principal Investigator:
          • Alice S. Ryan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: Single

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
Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention
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
Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention
0-10 numeric rating
Measured at baseline, after 6 weeks control, and after 6 week intervention
Fitness Change
Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention
VO2peak
Measured at baseline, after 6 weeks control, and after 6 week intervention
Strength Change
Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention
knee extensor strength
Measured at baseline, after 6 weeks control, and after 6 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2019

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 30, 2024

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)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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