Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| frozen gloves | Device | — | UNRESOLVED |
| hilotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- hilotherapy
- interventionNames
- Device: hilotherapy
- type
- ACTIVE_COMPARATOR
- label
- frozen gloves
- interventionNames
- Device: frozen gloves
Primary outcomes (1)
- measure
- any-grade incidence of side-effects at the extremities (peripheral neuropathy, pain, nail toxicity)
- timeFrame
- 24 weeks
Secondary outcomes (1)
- measure
- grade 2+ side-effects at the extremities (peripheral neuropathy, pain, nail toxicities)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available