Purpose

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

Eligibility

Eligible Ages
Between 60 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
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.
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland 21201
Contact:
Lynda C Robey
410-605-7000
lynda.robey@va.gov

More Details

Status
Recruiting
Sponsor
VA Office of Research and Development

Study Contact

Alice S Ryan, PhD
(410) 605-7851
Alice.Ryan@va.gov

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, and sensory thresholds (thermal, static, and dynamic) 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.