Exercise Effect on Chemotherapy-Induced Neuropathic Pain

NCT02991677 | Active Not Recruiting DMC

• 1 other identifier: HP-00070946
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

exercise; neuropathy

Outcome Measures

Primary Outcomes (1)

• Sensory pain

  Thermal, mechanical, and vibration sensation by quantitative sensory testing

  13 weeks

Secondary Outcomes (1)

• Nerve fiber density

  13 weeks

Study Arms (3)

control

OTHER

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

Other: control group

aerobic exercise

EXPERIMENTAL

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

Behavioral: aerobic exercise intervention

resistive training

EXPERIMENTAL

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

Behavioral: resistive training

Interventions

aerobic exercise intervention BEHAVIORAL

Exercise physiologist supervised walking or running on the treadmill 3 times weekly for 12 weeks.

aerobic exercise

control group OTHER

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

control

resistive training BEHAVIORAL

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

resistive training

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baltimore VA Medical Center: lead

Study Sites (1)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Alice Ryan, PhD

  University of Maryland at Baltimore School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 13, 2016
• Study Start: March 1, 2018
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

US (1)