Hilotherapy-study on Prevention of Oxaliplatin-induced Peripheral Neuropathy (HILO-OXALI)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Chemotherapy-induced Peripheral Neuropathy; Quality of Life

Treatments: Device: Hilotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04913376

S65284

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 Criteria:

• Already grade 2 or higher peripheral neuropathy

For a more detailed list, see protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Hilotherapy

Experimental group

Treatment:

Device: Hilotherapy

Standard care

No Intervention group