- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03621813
Exercise Rehabilitation in Veteran Cancer Survivors
Progressive Activity-Based Rehabilitation in Veteran Cancer Survivors With Chronic Pain
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alice S Ryan, PhD
- Phone Number: (410) 605-7851
- Email: Alice.Ryan@va.gov
Study Contact Backup
- Name: Lynda C Robey
- Phone Number: 5446 (410) 605-7000
- Email: lynda.robey@va.gov
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Recruiting
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
-
Contact:
- Lynda C Robey
- Phone Number: 5446 410-605-7000
- Email: lynda.robey@va.gov
-
Principal Investigator:
- Alice S. Ryan, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control
Participants maintain their current activity level.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Visual Analog Scale Change
Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention
|
Scale of 0 (no pain) to 100 (worst imaginable pain)
|
Measured at baseline, after 6 weeks control, and after 6 week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Reported Outcomes Measurement System Neuropathic Pain Quality (PROMIS-PQ Neuro) Change
Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention
|
0-10 numeric rating
|
Measured at baseline, after 6 weeks control, and after 6 week intervention
|
Fitness Change
Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention
|
VO2peak
|
Measured at baseline, after 6 weeks control, and after 6 week intervention
|
Strength Change
Time Frame: Measured at baseline, after 6 weeks control, and after 6 week intervention
|
knee extensor strength
|
Measured at baseline, after 6 weeks control, and after 6 week intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alice S. Ryan, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E2870-P
- HP-00081388 (Other Identifier: Baltimore VAMC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on Control
-
Claudia M. WittCompleted
-
University of California, San FranciscoWithdrawn
-
The George InstituteChanghai Hospital; University of CalgaryNot yet recruiting
-
Universidad Nacional de Educación a DistanciaMinisterio de Economía y Competitividad, SpainUnknownChronic Pain | FibromyalgiaSpain
-
University of California, Los AngelesThe National Council on Aging; City of Los Angeles Department of Aging; Los Angeles...Completed
-
Queen's University, BelfastPublic Health Agency, Health and Social Care Research and Development; Tiny...Completed
-
National Taiwan University HospitalEnrolling by invitationCognitive Function | Atrial Fibrillation, PersistentTaiwan
-
Takeshi MorimotoUniversity of the RyukyusActive, not recruitingCoronary Artery Disease | Hypertension | Type 2 Diabetes | DyslipidemiaJapan
-
Johnson & Johnson Vision Care, Inc.TerminatedRefractive Error CorrectionUnited States
-
Vanderbilt University Medical CenterCompleted