Exercise Rehabilitation in Veteran Cancer Survivors

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT03621813

Collaborator

Baltimore VA Medical Center (U.S. Fed)

Enrollment

Location

Arms

52.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Exercise Rehabilitation Other: Control	N/A

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

Cancer survivors will be enrolled in a 6-week delayed entry control period followed by 6-week exercise rehabilitation program.Cancer survivors will be enrolled in a 6-week delayed entry control period followed by 6-week exercise rehabilitation program.

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 19, 2019

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
Fitness Change [Measured at baseline, after 6 weeks control, and after 6 week intervention]
VO2peak
Strength Change [Measured at baseline, after 6 weeks control, and after 6 week intervention]
knee extensor strength

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

VA Office of Research and Development
Baltimore VA Medical Center

Investigators

Principal Investigator: Alice S. Ryan, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT03621813

Other Study ID Numbers:

E2870-P
HP-00081388

First Posted:

Aug 8, 2018

Last Update Posted:

Jan 11, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by VA Office of Research and Development

Neuropathic Pain

Exercise

Lung Cancer

Study Results

No Results Posted as of Jan 11, 2022