Clinical trial NCT03621813: Exercise Rehabilitation in Veteran Cancer Survivors
Official title: Progressive Activity-Based Rehabilitation in Veteran Cancer Survivors With Chronic Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Neuropathic Pain
Exercise
Lung Cancer
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Baltimore VA Medical Center
First posted: 2018-08-08
Enrollment: 9
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
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

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.

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

Primary outcomes:
measure: Pain Visual Analog Scale Change
timeFrame: Measured at baseline, after 6 weeks control, and after 6 week intervention
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement System Neuropathic Pain Quality (PROMIS-PQ Neuro) Change
timeFrame: Measured at baseline, after 6 weeks control, and after 6 week intervention
measure: Fitness Change
timeFrame: Measured at baseline, after 6 weeks control, and after 6 week intervention
measure: Strength Change
timeFrame: Measured at baseline, after 6 weeks control, and after 6 week intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Alice S. Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: