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

Study Name
	Effects of Exercise and Nutritional Interventions During Platinum Chemotherapy on Neuropathy: Examining the Interoceptive Brain System and Inflammation
ClinicalTrials.gov Identifier (if applicable)
	NCT05452902
Clinical Trial Category (check all that apply)
	Other Novel Therapy
Study Center
Institution Name
	University of Maryland, Baltimore
Institution Address
	655 W Lombard St, Baltimore, MD 21201
City
	Baltimore
State
	Maryland
Zip Code
	21201
Country
	United States
Phone
	(410) 706-7391
Website
	http://www.iankleckner.com/
List additional Institutions (include address, phone number, and website)
	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
Study Contacts
Principal Investigator
	Dr. Ian Kleckner
P.I. Phone
	(410) 706-5981
P.I. Email
	ian.kleckner@umaryland.edu
Study Coordinator
	Javier Rosales
Study Coordinator Phone
	(410) 706-7391
Study Coordinator Email
	jrosales@umaryland.edu
List additional Study Coordinators (include phone number and email)
	Amelia Wagenknecht (202)503 4411 awagenknecht@umaryland.edu
OVERVIEW – in layman’s terms (150 words max)
	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
	4
Study Start Date
	10/25/2022
Estimated Completion Date
	12/01/2025
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	The study the effects of exercise and/or nutrition on chemotherapy-induced peripheral neuropathy
Inclusion Criteria – Patients Must:
	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 – Patients Must NOT:
	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 BEGINNING STUDY TREATMENT – in layman’s terms
	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 – in layman’s terms
	Fatigue from exercise (minimal).
Financial Assistance is available to participants for travel, lodging, etc.
	Yes