Clinical trial · Interventional
Exercise to Reduce Chemotherapy-Induced Peripheral Neuropathy
Exercise to Reduce Chemotherapy-Induced Peripheral Neuropathy: A Pilot RCT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MI-Walk Intervention | Behavioral | — | UNRESOLVED |
| Physical Activity Education Pamphlet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MI-Walk Intervention
- description
- 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).
- interventionNames
- Behavioral: MI-Walk Intervention
- Behavioral: Physical Activity Education Pamphlet
- type
- ACTIVE_COMPARATOR
- label
- PA Education Alone
- description
- Subjects who are already receiving oxaliplatin prescribed by their oncologist (as standard of care) will receive a physical activity education pamphlet.
- interventionNames
- Behavioral: Physical Activity Education Pamphlet
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKanzawa-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 38954929