| ClinicalTrials.gov Identifier |
| NCT05452902 |
| Institution Name |
| University of Maryland, Baltimore |
| Institution Address (Street) |
| 655 W Lombard St, Baltimore, MD 21201 |
| Institution City |
| Baltimor |
| Institution State |
| Maryland |
| Institution ZIP Code |
| 21201 |
| Institution Country |
| United States |
| Institution Phone |
| (410) 706-7391 |
| Institution Website |
| http://www.iankleckner.com/ |
| Additional Institutions |
- University of Maryland, Upper Chesapeake Kaufman Cancer Center
- Marlene and Stewart Greenebaum Cancer Center
- UM St. Joseph Medical Center
- UM Baltimore Washington Medical Center
- UM Shore Medical Center at Easton
- UM Shore Medical Center at Chestertown
- UM Shore Medical Center at Dorchester
- UM Shore Regional Health
- UM Upper Chesapeake Health
- UM Upper Chesapeake Medical Center
|
| Principal Investigator |
| Dr. Ian Kleckner |
| Principal Investigator Phone |
| (410) 706-5981 |
| Principal Investigator Email |
| ian.kleckner@umaryland.edu |
| Study Coordinator |
| Javier Rosales |
| Study Coordinator Phone |
| (410) 706-7391 |
| Study Coordinator Email |
| jrosales@umaryland.edu |
| Additional Study Coordinators |
| Amelia Wagenknecht
(202)503 4411
awagenknecht@umaryland.edu |
| Study Overview |
| Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. 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. |
| Enrollment Information |
| 4 |
| Study Start Date |
| 20221025 |
| Study End Date |
| 20251201 |
| Study Purpose |
- The study the effects of exercise and/or nutrition on chemotherapy-induced peripheral neuropathy
|
| Inclusion Criteria |
- Have a diagnosis of cancer
- Be scheduled to receive oxaliplatin or cisplatin- chemotherapy without other neurotoxic chemotherapy (taxanes, bortezomib, thalidomide). Patients may be enrolled before their first (preferred), second, or third infusion of neurotoxic chemotherapy.
- Be ≥ 18 years
- Be able to read English
|
| Exclusion Criteria |
- Be performing regular exercise, which is any planned physical activity (e.g., brisk walking, aerobics, jogging, bicycling, swimming, rowing, weight lifting, resistance training, yoga, pilates, etc.) performed to increase physical fitness. To be considered exercise, physical activity should be performed 3-5 times per week for 20-60 minutes per session and should be done at a level that increases your breathing rate and causes you to break a sweat.
- 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.
- Have planned surgery or radiation treatment in the 12 weeks after baseline.
|
| Required Tests Prior to Study |
- Health Screening Questionnaires
- 1 Week Prior-Wearing a FitBit (to track daily steps)
- 1 Week Prior-Daily Diary
- Physical Testing (6 Minute Walk Test, Balance Testing)
- Touch Test (Fingertip and Toes)
- MRI Screening Questionnaire
|
| Potential Side Effects |
- Fatigue from exercise (minimal).
|
| Financial Assistance Available |
| Yes |
