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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Glove-Compression Therapy | Experimental | 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. |
|
| non-compressive plastic gloves | Placebo Comparator | Patients wore non-compressive plastic gloves, covered by large cotton gloves on both hands, for 30 minutes before, during, and after chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical Glove-Compression Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy using CTCAE version 5.0. | 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. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE versions 5.0 | 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. | 9 weeks |
| FACT/GOG-NTX scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saowani Thantaviraya, M.D. | Contact | +66805564241 | saowani.mook@gmail.com | |
| Sunatee Sa-nguansai, M.D. | Contact | +66896949358 | sunatee@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sunatee Sa-nguansai, M.D. | Department of Medical Services Ministry of Public Health of Thailand | Study Director |
| Saowani Thantaviraya, M.D. | Department of Medical Services Ministry of Public Health of Thailand |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi Hospital, Medical Oncology Unit | Recruiting | Bangkok | Bangkok | 10400 | Thailand |
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December 2024 - December 2025
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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.
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| non-compressive plastic gloves | Device | 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. |
|
FACT/GOG-NTX scores in both the intervention and the control group. |
| 9 weeks |
| Incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy using the PNQ | 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. | 9 weeks |
| Monofilament test results | Monofilament test results in both the intervention and the control group. | 9 weeks |
| Kunlatida Maneenil, M.D. | Department of Medical Services Ministry of Public Health of Thailand | Principal Investigator |
| Piyawan Tienchaiananda, M.D. | Department of Medical Services Ministry of Public Health of Thailand | Principal Investigator |
| Songwit Payapwattanawong, M.D. | Department of Medical Services Ministry of Public Health of Thailand | Principal Investigator |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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