Exercise Effect on Chemotherapy-Induced Neuropathic Pain

Baltimore VA Medical Center

Status: Active, not recruiting

Conditions: Cancer, Lung; Cancer, Colorectal; Cancer, Breast; Cancer, Ovarian

Treatments: Other: control group; Behavioral: aerobic exercise intervention; Behavioral: resistive training

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02991677

HP-00070946

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

control

Other group

Description:

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

Treatment:

Other: control group

aerobic exercise

Experimental group

Description:

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

Treatment:

Behavioral: aerobic exercise intervention

resistive training

Experimental group

Description:

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

Treatment:

Behavioral: resistive training