Clinical trial NCT06763575: Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy
Official title: Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paclitaxel-induced Peripheral Neuropathy
Keywords: Paclitaxel
Surgical Glove-Compression Therapy
Peripheral Neuropathy
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2025-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy using CTCAE version 5.0.
timeFrame: 9 weeks
Secondary outcomes:
measure: Incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE versions 5.0
timeFrame: 9 weeks
measure: FACT/GOG-NTX scores
timeFrame: 9 weeks
measure: Incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy using the PNQ
timeFrame: 9 weeks
measure: Monofilament test results
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital, Medical Oncology Unit
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Sunatee Sa-nguansai, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Saowani Thantaviraya, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Kunlatida Maneenil, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Piyawan Tienchaiananda, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Songwit Payapwattanawong, M.D.
role: PRINCIPAL_INVESTIGATOR
References: