The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy

NCT ID: NCT05771974

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-13
• Study Completion Date: 2026-09-30

Brief 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.

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Compression therapy using surgical gloves

Study participants wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion

Group Type: EXPERIMENTAL

Compression therapy using surgical gloves

Intervention Type: DEVICE

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

Control

No intervention is provided on both hands.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Compression therapy using surgical gloves

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Young-Joon Kang

OTHER

Sponsor Role: lead

Responsible Party

Young-Joon Kang

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Incheon St. Mary's Hospital

Incheon, Bupyeong, South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 37340369 (View on PubMed)

Other Identifiers

AIUR trial

Identifier Type: -

Identifier Source: org_study_id