Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Rajavithi Hospital
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy using CTCAE version 5.0.
Study Overview
Brief Summary
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
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Surgical Glove-Compression Therapy
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.
Intervention: Surgical Glove-Compression Therapy (Device)
non-compressive plastic gloves
Patients wore non-compressive plastic gloves, covered by large cotton gloves on both hands, for 30 minutes before, during, and after chemotherapy.
Intervention: non-compressive plastic gloves (Device)
Outcomes
Primary Outcomes
Incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy using CTCAE version 5.0.
Time Frame: 9 weeks
The incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy was evaluated using the CTCAE version 5.0 for both the intervention and control groups.
Secondary Outcomes
- Incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE versions 5.0(9 weeks)
- FACT/GOG-NTX scores(9 weeks)
- Incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy using the PNQ(9 weeks)
- Monofilament test results(9 weeks)