Actively Recruiting
Efficacy of Surgical Glove-Compression Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy A Randomized Controlled Trial Comparing Surgical Glove-Compression Therapy and Non-Compressive Gloves
Led by Department of Medical Services Ministry of Public Health of Thailand · Updated on 2025-01-08
36
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether surgical glove-compression therapy (SGCT) can prevent sensory peripheral neuropathy caused by the chemotherapy drug paclitaxel. This randomized controlled trial compares the incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy between patients using SGCT and those using non-compressive plastic gloves. The study also assesses motor neuropathy and other related symptoms using standardized questionnaires and tests. Participants are randomly assigned to one of two groups. The intervention group wears double-layered surgical gloves, one size smaller than their measured hand size, covered by large cotton gloves on both hands, for 30 minutes before, during, and after chemotherapy. The control group wears non-compressive plastic gloves covered by large cotton gloves for the same duration. Treatment and glove use continue for a total of 9 weeks. Throughout the study, patients are monitored at weeks 0, 3, 6, and 9 during their chemotherapy treatment. Assessments include grading neuropathy severity using the CTCAE version 5.0, patient questionnaires on neurotoxicity, and sensory tests like the monofilament test. Data are gathered by oncology staff and analyzed using descriptive and inferential statistics to determine the effectiveness of SGCT in reducing neuropathy.
CONDITIONS
Official Title
Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients who received chemotherapeutic agents that could cause neuropathy, such as taxane-based or platinum-based chemotherapy and anti-microtubule agents
- History of neuropathy
- History of carpal tunnel syndrome
- History of allergic reactions to latex or gloves
- Patients receiving treatments that may treat neuropathy, such as amitriptyline, gabapentin, Acetyl L-Carnitine, 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 with HbA1c greater than 6.5
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Trial Site Locations
Total: 1 location
1
Rajavithi Hospital, Medical Oncology Unit
Bangkok, Bangkok, Thailand, 10400
Actively Recruiting
Research Team
S
Saowani Thantaviraya, M.D.
S
Sunatee Sa-nguansai, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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