Exercise Effect on Chemotherapy-Induced Neuropathic Pain

Cancer, Breast Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02991677
• Other study ID #: HP-00070946
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Baltimore VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast
• Cancer, Colorectal
• Cancer, Lung
• Cancer, Ovarian
• Colorectal Neoplasms
• Lung Neoplasms
• Neuralgia
• Ovarian Neoplasms

Intervention

Behavioral:
• aerobic exercise intervention
Exercise physiologist supervised walking or running on the treadmill 3 times weekly for 12 weeks.

Other:
• control group
weekly contact by study staff with survivorship information offered not related to neuropathy.

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

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Baltimore VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory pain	Thermal, mechanical, and vibration sensation by quantitative sensory testing	13 weeks
Secondary	Nerve fiber density	laboratory examination of skin biopsy samples for measurement of nerve fiber density	13 weeks