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.
Description
- The study aims to test the hypothesis that SGCT is effective in preventing paclitaxel-induced peripheral neuropathy.
- 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.
- Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 36 patients.
- 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.
- 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.
- Data assessment will be conducted on weeks 0, 3, 6, and 9 during the chemotherapy treatment.
- Data analyzed by descriptive and inferential statistics.
Eligibility
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