Exercise to Reduce Chemotherapy-Induced Peripheral Neuropathy
2 other identifiers
interventional
54
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2018
CompletedFirst Posted
Study publicly available on registry
May 3, 2018
CompletedStudy Start
First participant enrolled
June 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2019
CompletedMarch 9, 2020
March 1, 2020
1 year
April 22, 2018
March 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Sensory neuropathy 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).
At 8 weeks
Secondary Outcomes (5)
Motor Neuropathy at 8 weeks
At 8 weeks
Autonomic Neuropathy at 8 weeks
At 8 weeks
Oxaliplatin dose at 8 weeks
At 8 weeks
Quality of life at 8 weeks
At 8 weeks
Mood at 8 weeks
At 8 weeks
Other Outcomes (7)
Exercise Adherence - Weekly Minutes of Moderate to Vigorous Physical Activity (MVPA)
Week 1 to week 8
Total Daily Minutes of MVPA at 8 weeks
At 8 weeks
Adapted Acceptability E-scale
8 weeks
- +4 more other outcomes
Study Arms (2)
MI-Walk Intervention
EXPERIMENTALSubjects 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).
PA Education Alone
ACTIVE COMPARATORSubjects who are already receiving oxaliplatin prescribed by their oncologist (as standard of care) will receive a physical activity education pamphlet.
Interventions
Eight-week motivational enhancement therapy and home-based aerobic walking intervention
Physical activity education pamphlet only
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michigan Rogel Cancer Centerlead
- Unity Health Torontocollaborator
Study Sites (7)
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48197, United States
St. Joseph Mercy Brighton Health Center
Brighton, Michigan, 48114, United States
Brighton Center for Specialty Care
Brighton, Michigan, 48116, United States
St. Joseph Mercy Health System
Canton, Michigan, 48188, United States
St. Joseph Mercy Chelsea Cancer Center
Chelsea, Michigan, 48118, United States
The University of Michigan Northville Health Center
Northville, Michigan, 48168, United States
Related Publications (1)
Kanzawa-Lee GA, Larson JL, Resnicow K, Ploutz-Snyder R, Krauss JC, Smith EML. Home-based aerobic exercise feasibility in oxaliplatin-receiving newly-diagnosed cancer survivors. Eur J Oncol Nurs. 2024 Aug;71:102649. doi: 10.1016/j.ejon.2024.102649. Epub 2024 Jun 27.
PMID: 38954929DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2018
First Posted
May 3, 2018
Study Start
June 13, 2018
Primary Completion
June 24, 2019
Study Completion
June 24, 2019
Last Updated
March 9, 2020
Record last verified: 2020-03