Clinical trial NCT05771974: The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Official title: A Randomized Controlled Trial Using Surgical Gloves to Prevent Chemotherapy-induced Peripheral Neuropathy by Paclitaxel in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 104
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Changes in the 11 items neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX) Therapy subscale
timeFrame: Before starting paclitaxel course (baseline), and 1~2 weeks from finishing paclitaxel course chemotherapy (target)
Secondary outcomes:
measure: Changes in 16 items component of the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) Therapy subscale
timeFrame: Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
measure: Changes in 27 items component of the Functional Assessment of Cancer Therapy-General (FACT-G) scale
timeFrame: Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
measure: Changes in the 11 items neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX) Therapy subscale at additional periods.
timeFrame: During paclitaxel course (about 1.5 months after starting) and six months after finishing paclitaxel course
measure: Change in National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) for CIPN
timeFrame: Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
measure: Comfort with intervention scale score
timeFrame: during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital
state: Bupyeong
Study officials:
References:
citation: 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.