Hilotherapy-study on Prevention of Oxaliplatin-induced Peripheral Neuropathy

NCT ID: NCT04913376

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2022-10-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Quality of Life Chemotherapy-induced Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial with stratification.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hilotherapy

Group Type EXPERIMENTAL

Hilotherapy

Intervention Type DEVICE

Constant cooling device for hands and feet.

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hilotherapy

Constant cooling device for hands and feet.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* Gastro-intestinal tumor, treated in UZ Leuven (University Hospitals of Leuven)
* Starting oxaliplatin-based treatment

Exclusion Criteria

* Already grade 2 or higher peripheral neuropathy

For a more detailed list, see protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annemarie Coolbrandt, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Leuven

Leuven, Flemish-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S65284

Identifier Type: -

Identifier Source: org_study_id

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