The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy (AIUR)

A Randomized Controlled Trial Using Surgical Gloves to Prevent Chemotherapy-induced Peripheral Neuropathy by Paclitaxel in Breast Cancer Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Device: Compression therapy using surgical gloves

Detailed Description

Chemotherapy-induced peripheral neuropathy (CIPN) is associated with side effects of taxanes, including paclitaxel. The common side effect may adversely affect the quality of life. However, no treatment for CIPN can be strongly recommended. Therefore, prevention is important. Cryotherapy, compression therapy, and exercise therapy can be considered for prevention, but no definitive recommendations are available. Studies with wider sample sizes are needed to confirm the efficacy and the preventive methods are complex for application. The study use surgical gloves for compression therapy to reduce discomfort and increase compliance with the procedure.

Patients with stage II-III breast cancer who receive paclitaxel chemotherapy for at least 12 weeks in six academic hospitals in South Korea will participate in the study. The study design is a multicenter, open-label, randomized controlled trial. The patients are randomly assigned to intervention or control groups. Intervention patients will wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion. The primary outcome is to demonstrate the preventive effect of compression therapy using surgical gloves as measured by the change in the neurotoxicity of FACT-Tax questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Bupyeong
    • Incheon, Bupyeong, South Korea, 21431
      • Incheon St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention is provided on both hands.
Experimental: Compression therapy using surgical gloves; Study participants wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion	Device: Compression therapy using surgical gloves; Intervention group wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the 11 items neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX) Therapy subscale	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.	Before starting paclitaxel course (baseline), and 1~2 weeks from finishing paclitaxel course chemotherapy (target)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in 16 items component of the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) Therapy subscale	The score changes in 16 items (neurotoxicity and taxane) component of the FACT-Taxane scale will be compared between the two groups. The FACT-Taxane is 5-point Likert-type scale. Each item measures on a 0-4 scale (0, not at all; 4, very much). A scale of 0 indicates a better outcome, and 4 indicates a worse outcome.	Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
Changes in 27 items component of the Functional Assessment of Cancer Therapy-General (FACT-G) scale	The score changes in general 27 items component of the FACT-G scale will be compared between the two groups. The FACT-G consists of four well-being subscales; physical well-being (7-item), social/family well-being (7-item), emotional well-being (6-item), and functional well-being (7-item). The FACT-G is 5-point Likert-type scale (0, not at all; 4, very much). For physical and emotional well-being, the higher the sum of scores, the lower the quality of life; for social/family and functional well-being, the higher the sum of scores, the higher the quality of life.	Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
Change in National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) for CIPN	NCI-CTCAE for CIPN is a method for reporting adverse event severity by a combination of clinical evaluation. The adverse effects of CIPN to be investigated are peripheral motor, sensory neuropathy, dysesthesia, paresthesia, neuralgia, and skin/nail toxicity.	Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
Comfort with intervention scale score	Comfort with the intervention (two-layer of surgical gloves) will be assessed on 4-point scale. The points are classified 0=dissatisfied; 1=not satisfied; 2=satisfied; 3=very satisfied.	during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
Changes in the 11 items neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX) Therapy subscale at additional periods.	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.	During paclitaxel course (about 1.5 months after starting) and six months after finishing paclitaxel course
FACT-NTX 11-item total score (continuous)	Mean FACT-NTX 11-item total score at each time point and change from baseline, analyzed using mixed-effects model for repeated measures (MMRM). Higher scores indicate greater neurotoxicity (range 0-44).	Baseline, during chemotherapy (mid-cycle), 1-2 weeks after completion of paclitaxel, and 6 months after completion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand-specific sub-score	FACT-NTX hand-specific sub-score (4 items: numbness/tingling in hands, discomfort in hands, trouble buttoning buttons, difficulty feeling shape of small objects; 0-16). The intervention directly targets the upper extremities; this sub-score is expected to capture the primary treatment effect.	Baseline, during chemotherapy, 1-2 weeks after completion, 6 months after completion
Foot-specific sub-score	FACT-NTX foot-specific sub-score (numbness/tingling in feet, discomfort in feet, trouble walking; 0-12). Internal control to assess body-region specificity of intervention effect	Baseline, during chemotherapy, 1-2 weeks after completion, 6 months after completion
Subgroup analysis	Subgroup analysis by paclitaxel schedule (weekly 80 mg/m² × 12 vs 3-weekly 175 mg/m² × 4): primary and secondary outcomes	1-2 weeks after completion of paclitaxel

Collaborators and Investigators

• Sponsor: Young-Joon Kang

Publications and helpful links

General Publications

• Kang 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2023
• Primary Completion (Actual): December 17, 2025
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: AIUR trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No