Hilotherapy-study on Prevention of Oxaliplatin-induced Peripheral Neuropathy

Last updated: July 1, 2024
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Completed

Phase

N/A

Condition

Neurologic Disorders

Treatment

Hilotherapy

Clinical Study ID

NCT04913376
S65284
  • Ages > 18
  • All Genders

Study Summary

Effectiveness of hilotherapy for the prevention of oxaliplatin-induced peripheral neuropathy and pain in the treatment of gastrointestinal tumors: A randomized controlled trial.

Eligibility Criteria

Inclusion

Most important Eligibility Criteria:

Inclusion Criteria:

  • 18 years or older

  • Gastro-intestinal tumor, treated in UZ Leuven (University Hospitals of Leuven)

  • Starting oxaliplatin-based treatment

Exclusion

Exclusion Criteria:

  • Already grade 2 or higher peripheral neuropathy

For a more detailed list, see protocol.

Study Design

Total Participants: 66
Treatment Group(s): 1
Primary Treatment: Hilotherapy
Phase:
Study Start date:
May 17, 2021
Estimated Completion Date:
October 25, 2022

Study Description

This study investigates whether constant cooling of the hands and feet using Hilotherm ChemoCare devices reduces the incidence of (severe) oxaliplatin-induced peripheral neuropathy and pain compared to standard care (i.e. no hand and foot cooling) in patients with gastrointestinal tumors.

Connect with a study center

  • UZ Leuven

    Leuven, Flemish-Brabant 3000
    Belgium

    Site Not Available

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