Exercise Rehabilitation in Veteran Cancer Survivors

NCT03621813 | Active Not Recruiting DMC

• 2 other identifiers: E2870-PHP-00081388
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Neuropathic Pain; Exercise; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient-Reported Outcomes Measurement System Neuropathic Pain Quality (PROMIS-PQ Neuro) Change

  Measured at baseline, after 6 weeks control, and after 6 week intervention

• Fitness Change

  Measured at baseline, after 6 weeks control, and after 6 week intervention

• Strength Change

  Measured at baseline, after 6 weeks control, and after 6 week intervention

Study Arms (2)

Control

OTHER

Participants maintain their current activity level.

Other: Control

Exercise Rehabilitation

ACTIVE COMPARATOR

Participants will exercise 2x/week at training facilities and at home one day a week.

Behavioral: Exercise Rehabilitation

Interventions

Exercise Rehabilitation BEHAVIORAL

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.

Exercise Rehabilitation

Control OTHER

Participants are instructed to maintain current activity level and are monitored for changes.

Control

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of metastatic (stage IV)
• Life expectancy \< 6 months
• Musculoskeletal or medical conditions which preclude participation in an exercise program

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Baltimore VA Medical Center: collaborator

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Neoplasms; Neuralgia; Motor Activity; Lung Neoplasms

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Alice S. Ryan, PhD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 8, 2018
• Study Start: August 19, 2019
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)