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Exercise to Reduce Chemotherapy-Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT03515356
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
St. Joseph Hospital Health Center
Information provided by (Responsible Party):
University of Michigan Cancer Center

Brief Summary:
This randomized, controlled, pilot experiment will evaluate the effects of an aerobic walking intervention on OIPN (oxaliplatin-induced peripheral neuropathy) in patients with colorectal cancer who are already prescribed FOLFOX by their oncologists. FOLFOX is a standard oxaliplatin-based chemotherapy treatment for stage II-III colorectal cancer that causes oxaliplatin-induced peripheral neuropathy (OIPN) in 85-95% of patients.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: MI-Walk Intervention Behavioral: Physical Activity Education Pamphlet Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exercise to Reduce Chemotherapy-Induced Peripheral Neuropathy: A Pilot RCT
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MI-Walk Intervention

Subjects who are already receiving FOLFOX prescribed by their oncologist (as standard of care) will receive a physical education pamphlet.

In addition, subjects will receive 8-weeks of motivational enhancement therapy- and a home-based aerobic walking intervention. Motivational interviewing will be delivered with concurrent feedback and motivational techniques in 30-45-minute sessions at intervention orientation (T2), 2 weeks (T4), and 4 weeks (T5).

Behavioral: MI-Walk Intervention
Eight-week motivational enhancement therapy and home-based aerobic walking intervention

Behavioral: Physical Activity Education Pamphlet
Physical activity education pamphlet only

Active Comparator: PA Education Alone
Subjects who are already receiving FOLFOX prescribed by their oncologist (as standard of care) will receive a physical education pamphlet.
Behavioral: Physical Activity Education Pamphlet
Physical activity education pamphlet only




Primary Outcome Measures :
  1. Change in Severity of Tingling in the Toes and Feet [ Time Frame: Baseline to 12 weeks ]
    An 11-point Numeric Rating Scale (NRS) measure will be used to evaluate the severity of tingling in the toes/feet. The score will range from 0 (no tingling) to 10 (worst imaginable).


Secondary Outcome Measures :
  1. Change in Sensory Neuropathy [ Time Frame: Baseline to 12 weeks ]
    The 9-item European Organisation of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy Scale (CIPN20) sensory subscale will be used to measure sensory neuropathy. Each item is rated on a scale from 1 ("not at all") to 4 ("very much"), and the total raw score ranges from 9 to 36. The raw scores will be linearly transformed to a 0 to 100 scale (higher scores represent worse CIPN severity).

  2. Change in Motor Neuropathy [ Time Frame: Baseline to 12 weeks ]
    The 8-item EORTC QLQ-CIPN20 motor subscale will be used to measure motor neuropathy. Each item is rated on a scale from 1 ("not at all") to 4 ("very much"), and the total raw score ranges from 8 to 32. The raw scores will be linearly transformed to a 0 to 100 scale (higher scores represent worse CIPN severity).

  3. Change in Autonomic Neuropathy [ Time Frame: Baseline to 12 weeks ]
    The 3-item EORTC QLQ-CIPN20 autonomic subscale will be used to measure autonomic neuropathy. Each item is rated on a scale from 1 ("not at all") to 4 ("very much"), and the total raw score ranges from 3 to 12. The raw scores will be linearly transformed to a 0 to 100 scale (higher scores represent worse CIPN severity).

  4. Change in cumulative oxaliplatin dose [ Time Frame: Week 4 to week 12 ]
    Cumulative oxaliplatin dose (mg/m2 of oxaliplatin received) data will be gathered from the electronic medical record (EMR).

  5. Change in quality of life [ Time Frame: Baseline to 12 weeks ]
    The EORTC QLQ 30-Item Questionnaire (EORTC QLQ-C30) is a patient-reported measure of cancer-specific QOL. Participants rate the degree that each item has applied to them during the past week on a four-point Likert scale (1, not at all; 4, very much). The average of the item scores gives a raw score and the raw score will be transformed to a 0 to 100 scale. Higher scores indicate higher QOL.

  6. Change in mood [ Time Frame: Baseline to 12 weeks ]
    The 4-item emotional functioning (EF) subscale of the EORTC QLQ-C30 will be used to measure mood. Participants rate the degree that each item has applied to them during the past week on a four-point Likert scale (1, not at all; 4, very much). The average of the item scores gives a raw score and the raw score will be transformed to a 0 to 100 scale. Higher scores indicate improved mood.


Other Outcome Measures:
  1. Exercise Adherence - Weekly Minutes of Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: Week 4 to week 12 ]
    A heart rate-enabled pedometer will be used to objectively measure adherence in the experimental group. The mean "active minutes" (minutes of moderate-vigorous physical activity) over eight weeks will be collected from a web-based application synchronized with the pedometer.

  2. Change in Total Daily Minutes of MVPA [ Time Frame: Baseline to 12 weeks ]
    The ActiGraph GT3X--a blinded wrist or hip-worn triaxial accelerometer--will be used to objectively measure activity counts per minute. The counts per minute will be transformed to total daily minutes of MVPA.

  3. Adapted Acceptability E-scale [ Time Frame: 12 weeks ]
    The Acceptability E-Scale was adapted to assess acceptability of the walking intervention. Specifically, the survey asks participants to rate the difficulty, enjoyability, helpfulness in managing OIPN symptoms, and acceptability of the time requirement of the MI-Walk intervention. Each item is rated on a scale from one to five and the 15-item survey score ranges from 19 to 75.

  4. Adverse event incidence [ Time Frame: Week 4 to week 12 ]
    Intervention-related adverse event incidence will be monitored throughout the study, using brief semi-scripted telephone interviews.

  5. Motivational Interviewing (MI) Fidelity Measure at Study Initiation [ Time Frame: Day 1 ]
    An external MI expert will formally review the fidelity of an MI session, using established MI evaluation criteria (the Motivational Interviewing Treatment Integrity Code [MITI]).

  6. MI Fidelity Measure Mid-Study [ Time Frame: 3 months ]
    An external MI expert will formally review the fidelity of an MI session, using the MITI.

  7. MI Fidelity Measure at 9 months [ Time Frame: 9 months ]
    An external MI expert will formally review the fidelity of an MI session, using the MITI.



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

Inclusion Criteria:

  • Diagnosed stage II to IV colorectal cancer;
  • Scheduled to receive FOLFOX;
  • Receiving care at the UM Multidisciplinary Colorectal Cancer Clinic in Ann Arbor or SJ in Ann Arbor;
  • A Karnofsky Performance Status ≥ 80% or an Eastern Cooperative Oncology Group Status 0 to 1;
  • Voluntarily consented to participate in all intervention components.

Exclusion Criteria:

  • Exercise- or mobility-limiting cardiovascular, pulmonary, musculoskeletal, or psychological disease, based on the EMR (electronic medical record) past medical history and consultation with the medical oncologist;
  • Scheduled major surgery during the study time period;
  • Pre-existing peripheral neuropathy (potentially due to diabetes, central nervous system malignancy, vitamin deficiency, heredity, nerve compression injury, non-surgically corrected carpal tunnel disease, or alcohol dependence) per patient self-report in response to brief screening questions noted in the pre-screening section;
  • Prior receipt of neurotoxic chemotherapy - taxanes (paclitaxel and docetaxel), platinums (cisplatin, oxaliplatin, and carboplatin), vinca alkaloids (vincristine and vinblastine), proteasome inhibitors (bortezomib), and thalidomide;
  • Already maintaining the national PA guidelines
  • Pregnancy;
  • Inability to read or speak English;
  • Prognosis of less than three months.

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): NCT03515356


Contacts
Contact: Grace Kanzawa-Lee, BSN, RN 734-846-4960 gracekan@umich.edu

Locations
United States, Michigan
The University of Michigan Comprehensive Cancer Center Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Grace Kanzawa-Lee, BSN, RN    734-846-4960    gracekan@umich.edu   
Principal Investigator: Grace Kanzawa-Lee, BSN, RN         
St. Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48197
Contact: Grace Kanzawa-Lee,, BSN, RN    734-846-4960    gracekan@umich.edu   
Principal Investigator: Grace Kanzawa-Lee, BSN, RN         
Principal Investigator: Philip Stella, MD         
Sponsors and Collaborators
University of Michigan Cancer Center
St. Joseph Hospital Health Center
Investigators
Principal Investigator: Grace Kanzawa-Lee, BSN, RN University of Michigan School of Nursing
Principal Investigator: Ellen M Lavoie Smith, PhD University of Michigan School of Nursing

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT03515356     History of Changes
Other Study ID Numbers: UMCC 2018.023
HUM00136639 ( Other Identifier: University of Michigan )
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Peripheral Nervous System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neuromuscular Diseases
Nervous System Diseases