search
Back to results

Exercise Effect on Chemotherapy-Induced Neuropathic Pain

Primary Purpose

Cancer, Breast, Cancer, Colorectal, Cancer, Lung

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aerobic exercise intervention
control group
resistive training
Sponsored by
Baltimore VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer, Breast focused on measuring exercise, neuropathy

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baltimore VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

control

aerobic exercise

resistive training

Arm Description

This is an attention control group with regular contact by study staff.

Aerobic exercise intervention is for 12 weeks 3 times weekly with training on site.

Intervention is for 12 weeks 3 times weekly with training on site.

Outcomes

Primary Outcome Measures

Sensory pain
Thermal, mechanical, and vibration sensation by quantitative sensory testing

Secondary Outcome Measures

Nerve fiber density
laboratory examination of skin biopsy samples for measurement of nerve fiber density

Full Information

First Posted
November 30, 2016
Last Updated
July 19, 2021
Sponsor
Baltimore VA Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02991677
Brief Title
Exercise Effect on Chemotherapy-Induced Neuropathic Pain
Official Title
Exercise Effect on Chemotherapy-Induced Neuropathic Pain, Peripheral Nerve Fibers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baltimore VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast, Cancer, Colorectal, Cancer, Lung, Cancer, Ovarian
Keywords
exercise, neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Other
Arm Description
This is an attention control group with regular contact by study staff.
Arm Title
aerobic exercise
Arm Type
Experimental
Arm Description
Aerobic exercise intervention is for 12 weeks 3 times weekly with training on site.
Arm Title
resistive training
Arm Type
Experimental
Arm Description
Intervention is for 12 weeks 3 times weekly with training on site.
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise intervention
Intervention Description
Exercise physiologist supervised walking or running on the treadmill 3 times weekly for 12 weeks.
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
weekly contact by study staff with survivorship information offered not related to neuropathy.
Intervention Type
Behavioral
Intervention Name(s)
resistive training
Intervention Description
Exercise physiologist supervised upper and lower extremity resistive training 3 times weekly for 12 weeks
Primary Outcome Measure Information:
Title
Sensory pain
Description
Thermal, mechanical, and vibration sensation by quantitative sensory testing
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Nerve fiber density
Description
laboratory examination of skin biopsy samples for measurement of nerve fiber density
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Ryan, PhD
Organizational Affiliation
University of Maryland at Baltimore School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Exercise Effect on Chemotherapy-Induced Neuropathic Pain

We'll reach out to this number within 24 hrs