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Chemotherapy-induced Peripheral NeuropathyAIURNCT05771974

The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy

A study testing Compression therapy using surgical gloves in people with Chemotherapy-induced Peripheral Neuropathy, run by Young-Joon Kang at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 69 years, women only
What is being tested?
Compression therapy using surgical gloves
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteSouth Korea
Study dates
13 Jun 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 69 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%)

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Incheon St. Mary's Hospital

    Incheon, Bupyeong, 21431

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
Compression therapy using surgical gloves

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compression therapy using surgical glovesDevice

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

Study groups in NCT05771974
Study groupRoleWhat they receive
Compression therapy using surgical glovesExperimentalStudy participants wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion
Receives: Device: Compression therapy using surgical gloves
ControlNo interventionNo intervention is provided on both hands.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Before starting paclitaxel course (baseline), and 1~2 weeks from finishing paclitaxel course chemotherapy (target)

Secondary outcomes (6)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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).

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

  5. 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.

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

  6. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start13 Jun 2023
  3. Primary completion17 Dec 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05771974
Sponsor's protocol ID
AIUR trial
Acronym
AIUR
Status last verified
Nov 2026
First submitted
6 Mar 2023
Last updated
6 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 37340369

Questions about this trial

What is this clinical trial studying?

A study testing Compression therapy using surgical gloves in people with Chemotherapy-induced Peripheral Neuropathy, run by Young-Joon Kang at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the 11 items neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX) Therapy subscale (time frame: Before starting paclitaxel course (baseline), and 1~2 weeks from finishing paclitaxel course chemotherapy (target)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05771974, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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