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NCT Number: NCT03858153

Exercise and Nutrition Interventions During Chemotherapy K07

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.

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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

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Maryland, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(subjects must…)

  • Be female
  • Have breast cancer
  • Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide)
  • Have at least six months life expectancy according to the patient's oncologist or designee
  • Be able to read English
  • Be at least 18 years old (no upper limit on age)
  • Provide written informed consent

Exclusion criteria

(subjects must not…)

  • Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
  • 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.

Additional exclusion criteria only for patients performing the MRI scanning (40 of 80 enrolled subjects)

  • Subjects must not have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, chest expander from breast reconstruction, etc.-note that most port-a-caths are safe for MRI scanning)

Treatment and study plan

EXCAP Exercise

Behavioral

12 weeks of at-home walking and resistance exercise.

Nutrition Education

Behavioral

12 weeks of implementing eating tips and tracking food.

Primary outcomes

  1. Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)

    Time frame: Time point 2 (approximately 6 weeks), controlling for baseline value

    CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).

Secondary outcomes

  1. Sensory loss

    Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline

    Finger tactile sensitivity

  2. Numbness and tingling

    Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline

    Patient-reported severity of numbness/tingling (0-10). A larger value reflects more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).

  3. Sensory, motor, and autonomic symptoms of CIPN

    Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline

    CIPN-20 total score (Postma et al 2005). The score includes 20 questions, each rated 1-4, and the score ranges from 20-80 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).

  4. Patient-reported sensory symptoms of CIPN

    Time frame: Time point 3 (approx. 12 weeks) or time point 4 (approx. 25 weeks), controlling for baseline

    CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).

Other outcomes

  1. Musculoskeletal function

    Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline

    Leg strength via isokinetic dynamometer test

  2. Cardiovascular function

    Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline

    Distance walked in six-minute walk test

  3. Neuropsychological function

    Time frame: Time point 2 (approx. 6 weeks), controlling for baseline

    Brain connectivity via functional magnetic resonance imaging

  4. Immunological function

    Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline

    Inflammatory cytokine concentration via ELISA (IL-6, IL-10, etc.)

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The Effects of Exercise and Nutrition Interventions on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2019
Registry last updated
Dec 22, 2025

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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