The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy

Young-Joon Kang

Status: Active, not recruiting

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Device: Compression therapy using surgical gloves

Study type: Interventional

Funder types: Other

Identifiers

NCT05771974

AIUR trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: Female

Ages: 19 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Compression therapy using surgical gloves

Experimental group

Description:

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

Treatment:

Device: Compression therapy using surgical gloves

Control

No Intervention group

Description:

No intervention is provided on both hands.