Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical Glove-Compression Therapy, non-compressive plastic gloves.
- Who it may be relevant to
- Registry conditions: Paclitaxel-induced Peripheral Neuropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Controlled Trial
Overview
The aim of this randomized controlled trial (RCT) is to compare the incidence of paclitaxel-induced grade 2 or higher sensory peripheral neuropathy, evaluated using the CTCAE version 5.0, between patients receiving surgical glove-compression therapy (SGCT) and those in the control group. The main question is whether SGCT is effective in preventing paclitaxel-induced sensory peripheral neuropathy. * Intervention group: receive SGCT. * Control group: receive non-compressive plastic gloves.
Detailed description
1. The study aims to test the hypothesis that SGCT is effective in preventing paclitaxel-induced peripheral neuropathy. 2. The primary objective is to determine the incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy, assessed using the CTCAE version 5.0. Secondary objectives include evaluating the incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE version 5.0, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) score, the incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy as measured by the Patient Neurotoxicity Questionnaire (PNQ), and the outcomes from the monofilament test. 3. Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 36 patients. 4. Randomization into two groups. The intervention arm will receive SGCT, while the control arm will receive non-compressive plastic gloves. The duration of treatment is 9 weeks. 5. Enrollment and data monitoring are assessed by staff at the Oncology Unit, Rajavithi Hospital, and the data will be recorded in a computer-based information system. 6. Data assessment will be conducted on weeks 0, 3, 6, and 9 during the chemotherapy treatment. 7. Data analyzed by descriptive and inferential statistics.
Interventions
- Device Surgical Glove-Compression Therapy
In the intervention group, patients wore double-layered surgical gloves, one size smaller than measured, covered by large cotton gloves on both hands, for 30 minutes before, during, and after chemotherapy. - Device non-compressive plastic gloves
In the control group, patients wore non-compressive plastic gloves, covered by large cotton gloves on both hands, for 30 minutes before, during, and after chemotherapy.
Primary outcome measures
- Incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy using CTCAE version 5.0. [Time frame: 9 weeks]
Secondary outcome measures (4)
- Incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE versions 5.0 [Time frame: 9 weeks]
- FACT/GOG-NTX scores [Time frame: 9 weeks]
- Incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy using the PNQ [Time frame: 9 weeks]
- Monofilament test results [Time frame: 9 weeks]
Eligibility criteria
Inclusion criteria
- Signed Informed Consent Form
- Age 18 years or older at the time of signing Informed Consent Form
- Patients with any pathological diagnosis of solid tumor, such as breast cancer or lung cancer
- Patients scheduled to be receiving intravenous paclitaxel or paclitaxel-based regimen every 3 weeks
Exclusion criteria
- Patients whose received chemotherapeutic agents that could cause neuropathy, e.g. taxane-based or platinum-based chemotherapy and anti-microtubule
- History of neuropathy
- History of carpal tunnel syndrome
- History of allergic reactions to latex or gloves
- Patients receiving treatments that may treat neuropathy, e.g. amitriptyline, gabapentin, Acetyl L-Carnitine and Ganglioside-monosialic acid, acupuncture, cryotherapy or exercise therapy
- History of Raynaud phenomenon
- History of wounds or large scars on hands
- Pregnancy or breastfeeding
- History of poorly controlled diabetes; HbA1c>6.5
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Thailand · 1 center
- Rajavithi Hospital, Medical Oncology Unit — Bangkok
Identifiers
NCT: NCT06763575 · 67171