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Completed

NCT Number: NCT03021174

Exercise and Nutrition Interventions During Chemotherapy

This is a feasibility pilot study to initiate a research program to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (numbness, tingling, and pain in the hands and feet).

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Key information

Conditions

Neuropathy;Peripheral Nervous System Diseases Neuritis Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

This is a feasibility pilot study to help obtain external funding for a larger study to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (CIPN), which is a dose-limiting and painful side effect of chemotherapy for which there are no established treatments. The investigators will conduct a two-arm randomized clinical trial in 40 cancer patients receiving chemotherapy where Arm 1 is 12 weeks of exercise during chemotherapy and Arm 2 is 12 weeks of nutrition education (control condition) during chemotherapy. The investigators will acquire data on CIPN via patient reports and clinical assessments as well as general pain and hypothetical mechanistic factors that may help explain how exercise may treat CIPN; these factors include measures of musculoskeletal, cardiovascular, neuropsychological, and immunological function. The primary outcomes are related to the feasibility of identifying, recruiting, and obtaining complete data from research participants.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have non-metastatic cancer
  • Be chemotherapy naïve
  • Be scheduled to receive CIPN-inducing chemotherapy during the study (platinums, vinca alkaloids, taxanes, thalidomide, or bortezomib) for the duration of the intervention (12 weeks)
  • Report symptoms of peripheral neuropathy at baseline (subject-reported severity of numbness and tingling in hands/feet of at least 1 on a 0-10 scale)
  • Be able to perform the exercise intervention
  • Be able to read English
  • Be at least 18 years old (no upper limit on age)
  • Be consistently right-handed in daily activities for consistency in reporting any lateralized effects from brain imaging
  • Provide written informed consent

Exclusion criteria

  • Receive surgery, radiation, or hormone therapy for their cancer during the study
  • Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
  • Have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, etc. - note that most port-a-caths are safe for MRI scanning)
  • Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.

Treatment and study plan

EXCAP Exercise

Behavioral

12 weeks of at-home walking and resistance exercise

Nutrition Education Control

Behavioral

12 weeks of implementing eating tips

Primary outcomes

  1. Percent of patients screened who are eligible

    Time frame: 12 weeks

    Number of patients eligible divided by number of patients screened

  2. Percent of patients eligible who are consented

    Time frame: 12 weeks

    Number of patients consented divided by number of patients approached

  3. Percent of patients consented who complete the exercise intervention

    Time frame: 12 weeks

    Number of patients in exercise arm who improve daily steps divided by number of patients in exercise arm

  4. Percent of patients consented who complete pre- and post-intervention measures of the patient-reported assessment of chemotherapy-induced peripheral neuropathy

    Time frame: 12 weeks

    Number of patients who completed pre- and post-intervention CIPN-20 questionnaire divided by number of patients consented (both arms)

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

A Feasibility Pilot Study on the Effects of Exercise on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2017
Registry last updated
Jul 18, 2019

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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