Paclitaxel-induced Peripheral Neuropathy
Conditions
Keywords
Paclitaxel, Surgical Glove-Compression Therapy, Peripheral Neuropathy
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
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
DEVICESurgical 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.
DEVICEnon-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.
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy using CTCAE version 5.0. | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE versions 5.0 | 9 weeks | The incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy was evaluated using the CTCAE version 5.0 in both the intervention and the control groups. |
| FACT/GOG-NTX scores | 9 weeks | FACT/GOG-NTX scores in both the intervention and the control group. |
| Incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy using the PNQ | 9 weeks | The incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy using the PNQ in both the intervention and the control group. |
| Monofilament test results | 9 weeks | Monofilament test results in both the intervention and the control group. |
Countries
Thailand
Contacts
Primary ContactSaowani Thantaviraya, M.D.
Backup ContactSunatee Sa-nguansai, M.D.
Outcome results
None listed