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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04659980

Enrollment

Registered

2020-12-09

Start date

2019-06-20

Completion date

2020-11-20

Last updated

2020-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DEVICEhilotherapy

continuous cooling of hands and feet at a constant temperature

DEVICEfrozen gloves

cooling of hands and feet using frozen gloves

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026