Using surgical gloves to prevent nerve damage from chemotherapy
A Randomized Controlled Trial Using Surgical Gloves to Prevent Chemotherapy-induced Peripheral Neuropathy by Paclitaxel in Breast Cancer Patients
This study tests if wearing surgical gloves during chemotherapy can help breast cancer patients avoid nerve damage caused by the treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 19 Years to 69 Years |
| Sex | Female |
| Sponsor | Incheon St.Mary's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Incheon, Bupyeong) |
| Trial ID | NCT05771974 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of compression therapy using surgical gloves to prevent chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer patients receiving paclitaxel. It is a multicenter, open-label, randomized controlled trial involving patients with stage II-III breast cancer who will wear surgical gloves during chemotherapy infusion. The primary outcome is measured through patient-reported outcome measures (PROMs), specifically the neurotoxicity component of the FACT-Tax questionnaire, comparing results between intervention and control groups. The goal is to establish a simple and compliant method to reduce the discomfort associated with CIPN.
Who should consider this trial
Good fit: Ideal candidates are patients aged 19 to 70 with stage II-III breast cancer scheduled to receive at least 12 weeks of paclitaxel chemotherapy.
Not a fit: Patients with a history of neuropathy, chronic kidney disease, or those currently using medications that mitigate CIPN may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients undergoing chemotherapy by reducing the incidence of peripheral neuropathy.
How similar studies have performed: While there is limited definitive evidence for the effectiveness of compression therapy in preventing CIPN, this approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Incheon, Bupyeong
- Incheon St. Mary's Hospital — Incheon, Bupyeong, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Young-Joon Kang
- Email: yjkang.md@gmail.com
- Phone: +82 32-280-5179
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.