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Trial Title:
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
NCT ID:
NCT05771974
Condition:
Chemotherapy-induced Peripheral Neuropathy
Conditions: Official terms:
Peripheral Nervous System Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Compression therapy using surgical gloves
Description:
Intervention group wear two-layer of normal-sized surgical gloves on both hands during
chemotherapy infusion
Arm group label:
Compression therapy using surgical gloves
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.
Criteria for 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
Gender:
Female
Minimum age:
19 Years
Maximum age:
69 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Incheon St. Mary's Hospital
Address:
City:
Incheon
Zip:
21431
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Young-Joon Kang, PhD
Phone:
+82 32-280-5179
Email:
yjkang.md@gmail.com
Start date:
June 13, 2023
Completion date:
February 2026
Lead sponsor:
Agency:
Young-Joon Kang
Agency class:
Other
Source:
Incheon St.Mary's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05771974
