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Exercise and Nutrition Interventions During Chemotherapy K07

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ClinicalTrials.gov Identifier: NCT03858153
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ian Kleckner, University of Rochester

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuropathy;Peripheral Behavioral: EXCAP Exercise Behavioral: Nutrition Education Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Assessor and investigator will be masked of Arms to the extent possible (i.e., for some outcomes e.g., biomarkers but not others e.g. symptom tests).
Primary Purpose: Supportive Care
Official Title: The Effects of Exercise and Nutrition Interventions on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise
Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.
 Behavioral: EXCAP Exercise
12 weeks of at-home walking and resistance exercise.
Active Comparator: Nutrition Education
Nutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.
 Behavioral: Nutrition Education
12 weeks of implementing eating tips and tracking food.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria (subjects must…)

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

Exclusion criteria (subjects must not…)

  1. Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
  2. 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)

1. 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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858153


Contacts
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Contact: Ian Kleckner, PhD, MPH 585-273-3256 ian_kleckner@urmc.rochester.edu
Contact: Susan Staples, BS 585-481-7200 susan_staples@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Ian Kleckner, PhD    585-273-3256    ian_kleckner@urmc.rochester.edu   
Sponsors and Collaborators
University of Rochester
National Cancer Institute (NCI)
More Information
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Publications:

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Responsible Party: Ian Kleckner, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03858153    
Other Study ID Numbers: STUDY00003387
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Interested researchers may contact the study PI with requests for collaboration.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ian Kleckner, University of Rochester:
chemotherapy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases