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Active, not recruiting Not applicable

The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy

NCT05771974 · tracked via the Priya Life Science South Korea tracker
Sponsor
Young-Joon Kang
Phase
Not applicable
Started
2023-06-13
Last updated
2026-02-27

Condition(s) studied

Chemotherapy-induced Peripheral Neuropathy

Investigational drug(s) / intervention(s)

Compression therapy using surgical gloves

Compression therapy using surgical gloves: Intervention group wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion

Study summary

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.

Eligibility

Sex
FEMALE
Min age
19 Years
Max age
69 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Changes in the 11 items neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX) Therapy subscale — Before starting paclitaxel course (baseline), and 1~2 weeks from finishing paclitaxel course chemotherapy (target)
    The change in FACT-NTX will be divided into a good outcome (change in FACT-NTX less than five from baseline to target timeframe) versus a poor outcome (change in FACT NTX greater than or equal to five from baseline to target timeframe). The difference in the number of poor outcome participants will compare between the two groups. The FACT-NTX is 5-point Likert-type scale. Each item measures on a 0-4 scale (0, not at all; 4, very much). A greater change in the FACT-NTX score was considered a clinically meaningful increase in CIPN.

Trial sites (1)

FacilityCityRegionStatus
Incheon St. Mary's Hospital Incheon Bupyeong

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05771974 on ClinicalTrials.gov ↗ ← All trials in South Korea