Exercise Rehabilitation in Veteran Cancer Survivors

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03621813
• Other study ID #: E2870-P
• Secondary ID: HP-00081388
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: Alice S Ryan, PhD
• Phone: (410) 605-7851
• Email: Alice.Ryan[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Other:
• Control
Participants are instructed to maintain current activity level and are monitored for changes.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Baltimore VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Fitness Change	VO2peak	Measured at baseline, after 6 weeks control, and after 6 week intervention
Secondary	Strength Change	knee extensor strength	Measured at baseline, after 6 weeks control, and after 6 week intervention