Effects of Exercise and Nutritional Interventions During Platinum Chemotherapy on Neuropathy: Examining the Interoceptive Brain System and Inflammation

ClinicalTrials.gov Identifier

NCT05452902

Institution Name

University of Maryland, Baltimore

Full Institution Address

655 W Lombard St, Baltimore, MD 21201 Baltimor Maryland 21201 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

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