Clinical trial · Interventional
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
A Randomized Controlled Trial Using Surgical Gloves to Prevent Chemotherapy-induced Peripheral Neuropathy by Paclitaxel in Breast Cancer Patients
- 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)
This study aims to demonstrate the preventive effect of compression therapy using surgical gloves in chemotherapy-induced peripheral neuropathy. Patient-reported outcome measures (PROMs) are utilized for comparing the change in neuropathic pain between intervention and control groups. Among the PROMs, the neurotoxicity component of the functional Assessment of Cancer Therapy-taxane (FACT-Tax) is used for good and poor outcomes between baseline and post-chemotherapy in paclitaxel-treated breast cancer patients.
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 |
|---|---|---|---|
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compression therapy using surgical gloves | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Compression therapy using surgical gloves
- description
- Study participants wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion
- interventionNames
- Device: Compression therapy using surgical gloves
- type
- NO_INTERVENTION
- label
- Control
- description
- No intervention is provided on both hands.
Primary outcomes (1)
- measure
- Changes in the 11 items neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX) Therapy subscale
- timeFrame
- Before starting paclitaxel course (baseline), and 1~2 weeks from finishing paclitaxel course chemotherapy (target)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater or equal to 19 years, under 70 years old * Stage II-III breast cancer * No distant metastasis * Patient scheduled to be receiving adjuvant or neoadjuvant paclitaxel for at least 12 weeks * Signed informed consent * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥60%) Exclusion Criteria: * Recurred breast cancer * Patients who have previously received treatment that could cause neuropathy; taxane or platinum-based chemotherapy, antitubulins, proteasome inhibitors * Known history of neuropathy * Chronic kidney disease * Raynaud's phenomenon * Peripheral vascular disease; peripheral arterial ischemia * Cold intolerance * Allergy in natural rubber latex or surgical gloves * Patients who have dermatitis, wound, or musculoskeletal problems in hand at enrollment * Current use medications which may mitigate chemotherapy-induced peripheral neuropathy; duloxetine, gabapentin/pregabalin, Baclofen-amitriptyline-ketamine (BAK; topical amitriptyline, ketamine, ±baclofen), oral cannabinoids, tricyclic antidepressants, ganglioside-monosialic acid
References
Publications (1)
- BACKGROUNDKang YJ, Yoon CI, Yang YJ, Baek JM, Kim YS, Jeon YW, Rhu J, Yi JP, Kim D, Oh SJ. A randomized controlled trial using surgical gloves to prevent chemotherapy-induced peripheral neuropathy by paclitaxel in breast cancer patients (AIUR trial). BMC Cancer. 2023 Jun 20;23(1):570. doi: 10.1186/s12885-023-11079-8. PMID 37340369