Exercise Effect on Chemotherapy-Induced Neuropathic Pain

August 5, 2024 updated by: Alice S. Ryan, PhD, Baltimore VA Medical Center

Exercise Effect on Chemotherapy-Induced Neuropathic Pain, Peripheral Nerve Fibers

Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare concern. It is painful, persistent, resistant to conventional pain therapies, and results in long-term suffering and decreased quality of life for many cancer survivors. The role of exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the goal of identifying the mechanisms associated with this therapeutic approach to manage CIPN-NP.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis with cancer, stage I-IV
  • History of treatment with oxaliplatin, docetaxel, or paclitaxel, either alone or in combination with other agents
  • Completion of chemotherapy > 6 months < 1 year
  • Ability to walk on a treadmill
  • Medical clearance from oncologist or primary care provider
  • Presence of CIPN per National Cancer Institute Common Toxicity Criteria grade 1-3 (0-no signs/symptoms, 1-minor loss of function, 2-increased symptoms not interfering with activities of daily living (ADLs), 3-severe symptoms interfering with ADL, 4-disabling, and 5 is death)
  • Score on Neuropathic Pain Scale >1
  • Age 21-70

Exclusion Criteria:

  • Denial of CIPN
  • Other motor/sensory neuropathy caused by other than chemotherapy (i.e.alcohol-related, autoimmune diseases, diabetes)
  • Coronary artery disease
  • History of >1 chemotherapy regimen
  • Musculoskeletal conditions which preclude participation in an exercise training program
  • Pregnancy
  • Regular exerciser, defined as >90 minutes per week of aerobic exercise and any resistive training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control
This is an attention control group with regular contact by study staff.
Other: control group
weekly contact by study staff with survivorship information offered not related to neuropathy.
Experimental: aerobic exercise
Aerobic exercise intervention is for 12 weeks 3 times weekly with training on site.
Behavioral: aerobic exercise intervention
Exercise physiologist supervised walking or running on the treadmill 3 times weekly for 12 weeks.
Experimental: resistive training
Intervention is for 12 weeks 3 times weekly with training on site.
Behavioral: resistive training
Exercise physiologist supervised upper and lower extremity resistive training 3 times weekly for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory pain
Time Frame: 13 weeks
Thermal, mechanical, and vibration sensation by quantitative sensory testing
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nerve fiber density
Time Frame: 13 weeks
laboratory examination of skin biopsy samples for measurement of nerve fiber density
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baltimore VA Medical Center

Investigators

  • Principal Investigator: Alice Ryan, PhD, University of Maryland at Baltimore School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (Estimated)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00070946

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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