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Active, Not Recruiting

NCT Number: NCT02991677

Exercise Effect on Chemotherapy-Induced Neuropathic Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic exercise intervention

Behavioral

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

Control Group

Other

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

resistive training

Behavioral

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

Primary outcomes

  1. Sensory pain

    Time frame: 13 weeks

    Thermal, mechanical, and vibration sensation by quantitative sensory testing

Secondary outcomes

  1. Nerve fiber density

    Time frame: 13 weeks

    laboratory examination of skin biopsy samples for measurement of nerve fiber density

Sponsors and collaborators

Lead sponsor

Baltimore VA Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2016
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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