A randomized controlled trial using surgical gloves to prevent chemotherapy-induced peripheral neuropathy by paclitaxel in breast cancer patients (AIUR trial)
- Conditions
- Neoplasms
- Registration Number
- KCT0008371
- Lead Sponsor
- The Catholic University of Korea, Incheon St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 104
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%)
-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, BAK (topical amitriptyline, ketamine, ±baclofen), oral cannabinoids, tricyclic antidepressants, ganglioside-monosialic acid
-Patients' condition that interferes with understanding and submitting the consent form
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the 11-item neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX) Therapy subscale
- Secondary Outcome Measures
Name Time Method Changes in 16 items (neurotoxicity and tax) component of the FACT-Taxane Therapy subscale;Changes in 27 items (general) component of the FACT (FACT-G) scale;Changes in FACT-NTX at additional periods ;Change in National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) for CIPN;Comfort with intervention scale score