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Exercise to Reduce Chemotherapy-Induced Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515356
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : March 9, 2020
Sponsor:
Collaborator:
St. Joseph Hospital Health Center
Information provided by (Responsible Party):
University of Michigan Rogel 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 gastrointestinal (GI) cancer who are already prescribed oxaliplatin (85 mg/m2 every other week for at least six cycles) by their oncologists. Oxaliplatin is a standard chemotherapy treatment for invasive GI cancers that causes OIPN in 85-95% of patients.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 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 : June 13, 2018
Actual Primary Completion Date : June 24, 2019
Actual Study Completion Date : June 24, 2019


Arm Intervention/treatment
Experimental: MI-Walk Intervention

Subjects who are already receiving oxaliplatin prescribed by their oncologist (as standard of care) will receive a physical activity 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 (T1), 2 weeks (T3), and 4 weeks (T4).

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 oxaliplatin prescribed by their oncologist (as standard of care) will receive a physical activity education pamphlet.
Behavioral: Physical Activity Education Pamphlet
Physical activity education pamphlet only




Primary Outcome Measures :
  1. Sensory neuropathy at 8 weeks [ Time Frame: At 8 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).


Secondary Outcome Measures :
  1. Motor Neuropathy at 8 weeks [ Time Frame: At 8 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).

  2. Autonomic Neuropathy at 8 weeks [ Time Frame: At 8 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).

  3. Oxaliplatin dose at 8 weeks [ Time Frame: At 8 weeks ]
    Cumulative oxaliplatin dose (mg/m2 of oxaliplatin received) data will be gathered from the electronic medical record (EMR).

  4. Quality of life at 8 weeks [ Time Frame: At 8 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.

  5. Mood at 8 weeks [ Time Frame: At 8 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 1 to week 8 ]
    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. Total Daily Minutes of MVPA at 8 weeks [ Time Frame: At 8 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: 8 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 1 to week 8 ]
    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: 6 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: 12 months ]
    An external MI expert will formally review the fidelity of an MI session, using the MITI.



Information from the National Library of Medicine

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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 GI cancer (e.g, colorectal, gastric, pancreatic, esophageal, bowel);
  • Scheduled to receive at least 6 cycles of oxaliplatin (85 mg/m2);
  • Receiving care at the University of Michigan or St. Joseph Cancer Clinics;
  • 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 prior to chemotherapy (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;
  • 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


Locations
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United States, Michigan
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48197
St. Joseph Mercy Brighton Health Center
Brighton, Michigan, United States, 48114
Brighton Center for Specialty Care
Brighton, Michigan, United States, 48116
St. Joseph Mercy Health System
Canton, Michigan, United States, 48188
St. Joseph Mercy Chelsea Cancer Center
Chelsea, Michigan, United States, 48118
The University of Michigan Northville Health Center
Northville, Michigan, United States, 48168
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
St. Joseph Hospital Health Center
Investigators
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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
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03515356    
Other Study ID Numbers: UMCC 2018.023
HUM00136639 ( Other Identifier: University of Michigan )
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Peripheral Nervous System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neuromuscular Diseases
Nervous System Diseases