TERMINATED

Exercise and Nutrition Interventions for Platinum Chemotherapy-induced Neuropathy R21

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. Unfortunately 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, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.

Official Title

The Effects of Exercise and Nutrition Interventions on Platinum Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry (R21)

Quick Facts

Study Start:2023-01-19
Study Completion:2025-09-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05452902

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

University of Maryland Medical System
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-19
Study Completion Date2025-09-25

Study Record Updates

Study Start Date2023-01-19
Study Completion Date2025-09-25

Terms related to this study

Keywords Provided by Researchers

  • Chemotherapy
  • Brain
  • Exercise
  • Nutrition

Additional Relevant MeSH Terms

  • Chemotherapy-induced Peripheral Neuropathy