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

NCT04659980 | Completed

• 1 other identifier: S62794
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• any-grade incidence of side-effects at the extremities (peripheral neuropathy, pain, nail toxicity)

  24 weeks

Secondary Outcomes (1)

• grade 2+ side-effects at the extremities (peripheral neuropathy, pain, nail toxicities)

  24 weeks

Study Arms (2)

hilotherapy

ACTIVE COMPARATOR

Device: hilotherapy

frozen gloves

ACTIVE COMPARATOR

Device: frozen gloves

Interventions

hilotherapy DEVICE

continuous cooling of hands and feet at a constant temperature

hilotherapy

frozen gloves DEVICE

cooling of hands and feet using frozen gloves

frozen gloves

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: June 20, 2019
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

BE (1)