Exercise Effect on Chemotherapy-Induced Neuropathic Pain

NCT ID: NCT02991677

Last Updated: 2024-08-06

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer, Breast Cancer, Colorectal Cancer, Lung Cancer, Ovarian

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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control

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

Group Type OTHER

control group

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

aerobic exercise intervention

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

resistive training

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

control group

weekly contact by study staff with survivorship information offered not related to neuropathy.

Intervention Type OTHER

resistive training

Exercise physiologist supervised upper and lower extremity resistive training 3 times weekly for 12 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baltimore VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Alice S. Ryan, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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HP-00070946

Identifier Type: -

Identifier Source: org_study_id

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