Exercise Effect on Chemotherapy-Induced Neuropathic Pain

Sponsor

Baltimore VA Medical Center (U.S. Fed)

Overall Status

Active, not recruiting

CT.gov ID

NCT02991677

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Breast Cancer, Colorectal Cancer, Lung Cancer, Ovarian	Behavioral: aerobic exercise intervention Other: control group Behavioral: resistive training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Sensory pain [13 weeks]
Thermal, mechanical, and vibration sensation by quantitative sensory testing

Secondary Outcome Measures

Nerve fiber density [13 weeks]
laboratory examination of skin biopsy samples for measurement of nerve fiber density

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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