Using surgical glove-compression therapy to prevent nerve damage from paclitaxel
Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Controlled Trial
This study tests if wearing special surgical gloves can help prevent nerve damage in cancer patients receiving paclitaxel chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Department of Medical Services Ministry of Public Health of Thailand Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bangkok, Bangkok) |
| Trial ID | NCT06763575 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of surgical glove-compression therapy (SGCT) in preventing sensory peripheral neuropathy caused by paclitaxel chemotherapy. Participants will be randomly assigned to either receive SGCT or non-compressive plastic gloves during their treatment. The study will assess the incidence of grade 2 or higher sensory peripheral neuropathy using established criteria and will also evaluate secondary outcomes related to motor neuropathy and overall neurotoxicity. Data will be collected at multiple time points throughout the chemotherapy regimen, and a total of 36 patients will be enrolled for this trial.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a solid tumor diagnosis scheduled to receive paclitaxel chemotherapy.
Not a fit: Patients with a history of neuropathy or those receiving other treatments for neuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of painful nerve damage in patients undergoing paclitaxel treatment.
How similar studies have performed: While the specific use of SGCT is novel, similar approaches in managing chemotherapy-induced neuropathy have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bangkok, Bangkok
- Rajavithi Hospital, Medical Oncology Unit — Bangkok, Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Saowani Thantaviraya, M.D. — Department of Medical Services Ministry of Public Health of Thailand
- Study coordinator: Saowani Thantaviraya, M.D.
- Email: saowani.mook@gmail.com
- Phone: +66805564241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.