The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy

NCT05771974 | Active Not Recruiting

• 1 other identifier: AIUR trial
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in 16 items component of the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) Therapy subscale

  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

  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 the 11 items neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX) Therapy subscale at additional periods.

  During paclitaxel course (about 1.5 months after starting) and six months after finishing paclitaxel course

• FACT-NTX 11-item total score (continuous)

  Baseline, during chemotherapy (mid-cycle), 1-2 weeks after completion of paclitaxel, and 6 months after completion

• Change in National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) for CIPN

  Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course

Other Outcomes (3)

• Hand-specific sub-score

  Baseline, during chemotherapy, 1-2 weeks after completion, 6 months after completion

• Foot-specific sub-score

  Baseline, during chemotherapy, 1-2 weeks after completion, 6 months after completion

• Subgroup analysis

  1-2 weeks after completion of paclitaxel

Study Arms (2)

Compression therapy using surgical gloves

EXPERIMENTAL

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

Device: Compression therapy using surgical gloves

Control

NO INTERVENTION

No intervention is provided on both hands.

Interventions

Compression therapy using surgical gloves DEVICE

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

Compression therapy using surgical gloves

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Young-Joon Kang: lead

Study Sites (1)

Incheon St. Mary's Hospital

Incheon, Bupyeong, 21431, South Korea

Location

Related Publications (1)

• 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.

  PMID: 37340369 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: June 13, 2023
• Primary Completion: December 17, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

KR (1)