Preventing Taxane-related Peripheral Neuropathy, Pain and Nail Toxicity: A Prospective Self-controlled Trial Comparing Hilotherapy With Frozen Gloves in Early Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: hilotherapy; Device: frozen gloves

• Registration Number: NCT04659980
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The prevention of taxane-related toxicities at the extremities is highly important for patients' treatment and quality-of-life. Unlike standard cryotherapy with frozen gloves, hilotherapy produces cooling at a constant temperature. Comparative data with frozen gloves are unavailable. This prospective self-controlled study explores the efficacy of hilotherapy at the right hand and foot compared to frozen gloves at the left in patients with early breast cancer treated with weekly paclitaxel 80 mg/m² or three-weekly docetaxel 75 mg/m².

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-20
• Primary Completion: 2020-11-20
• Study Completion: 2020-11-20
• Status Verified: 2020-12
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-09
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hilotherapy	hilotherapy	-
frozen gloves	frozen gloves	-

Primary Outcome Measures

Name	Time	Method
any-grade incidence of side-effects at the extremities (peripheral neuropathy, pain, nail toxicity)	24 weeks

Secondary Outcome Measures

Name	Time	Method
grade 2+ side-effects at the extremities (peripheral neuropathy, pain, nail toxicities)	24 weeks

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium