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

Breast Cancer Clinical Trial

Official title:

Hilotherapy vs Frozen Gloves for Preventing Taxane-related Peripheral Neuropathy, Pain and Nail Toxicity in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04659980
• Other study ID #: S62794
• Status: Completed
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: November 20, 2020

Study information

• Verified date: December 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• adult (=18 years) patients with breast cancer

• treated with weekly paclitaxel 80 mg/m² (12 cycles) or three-weekly docetaxel 75 mg/m² (4 or 6 cycles) in an adjuvant or neo-adjuvant setting.

Exclusion criteria:

• peripheral neuropathy or pain in the extremities at baseline, regardless of whether this was related to a prior chemotherapy treatment or another condition

• Raynaud's phenomenon, cold intolerance or any condition to the nails or peripheral blood vessels that could pose a risk to the compliance with the study interventions

• insufficient understanding of the Dutch language for self-reporting the side-effects under investigation

Patients were excluded from the analysis if they received less than two thirds of planned treatment cycles, for other reasons than the side-effects investigated in this study.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Peripheral Nervous System Diseases

Intervention

Device:
• hilotherapy
continuous cooling of hands and feet at a constant temperature
• frozen gloves
cooling of hands and feet using frozen gloves

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	any-grade incidence of side-effects at the extremities (peripheral neuropathy, pain, nail toxicity)		24 weeks
Secondary	grade 2+ side-effects at the extremities (peripheral neuropathy, pain, nail toxicities)		24 weeks