Exercise Effect on Chemotherapy-Induced Neuropathic Pain
NCT ID: NCT02991677
Last Updated: 2024-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2018-03-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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control
This is an attention control group with regular contact by study staff.
control group
weekly contact by study staff with survivorship information offered not related to neuropathy.
aerobic exercise
Aerobic exercise intervention is for 12 weeks 3 times weekly with training on site.
aerobic exercise intervention
Exercise physiologist supervised walking or running on the treadmill 3 times weekly for 12 weeks.
resistive training
Intervention is for 12 weeks 3 times weekly with training on site.
resistive training
Exercise physiologist supervised upper and lower extremity resistive training 3 times weekly for 12 weeks
Interventions
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aerobic exercise intervention
Exercise physiologist supervised walking or running on the treadmill 3 times weekly for 12 weeks.
control group
weekly contact by study staff with survivorship information offered not related to neuropathy.
resistive training
Exercise physiologist supervised upper and lower extremity resistive training 3 times weekly for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
70 Years
ALL
No
Sponsors
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Baltimore VA Medical Center
FED
Responsible Party
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Alice S. Ryan, PhD
Professor
Principal Investigators
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Alice Ryan, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland at Baltimore School of Medicine
Locations
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Baltimore VA Medical Center
Baltimore, Maryland, United States
Countries
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Other Identifiers
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HP-00070946
Identifier Type: -
Identifier Source: org_study_id
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