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

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Conditions

Breast Cancer

Treatments

Device: hilotherapy

Device: frozen gloves

Study type

Interventional

Funder types

Other

Identifiers

NCT04659980

S62794

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.