Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06763575

Efficacy of Surgical Glove-Compression Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy: Randomized Controlled Trial

Led by Department of Medical Services Ministry of Public Health of Thailand · Updated on 2025-01-08

36

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of surgical glove-compression therapy (SGCT) in preventing sensory peripheral neuropathy caused by paclitaxel chemotherapy. This randomized controlled trial compares the incidence of grade 2 or higher sensory peripheral neuropathy between patients using SGCT and those wearing non-compressive plastic gloves, aiming to find out if SGCT can reduce this side effect. The study also looks at motor neuropathy and other neuropathy-related scores and tests. Participants are randomly assigned to one of two groups. The intervention group wears 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. The control group wears non-compressive plastic gloves covered by large cotton gloves on both hands for the same duration. The treatment period lasts 9 weeks, coinciding with the chemotherapy schedule. During the study, data including neuropathy grades using CTCAE version 5.0, FACT/GOG-NTX scores, Patient Neurotoxicity Questionnaire results, and monofilament test outcomes are collected at weeks 0, 3, 6, and 9. Enrollment and monitoring are conducted by the Oncology Unit staff, with data recorded electronically. The primary outcome is the incidence of grade 2 or higher sensory neuropathy after 9 weeks. Statistical analyses are performed to evaluate the results, and the total participation lasts through the chemotherapy period.

CONDITIONS

Brief Title

Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed Informed Consent Form
  • Age 18 years or older at the time of signing Informed Consent Form
  • Diagnosis of any solid tumor, such as breast cancer or lung cancer
  • Scheduled to receive intravenous paclitaxel or paclitaxel-based chemotherapy every 3 weeks
Not Eligible

You will not qualify if you...

  • Previous treatment with chemotherapeutic agents that cause neuropathy, such as taxane-based or platinum-based chemotherapy and anti-microtubule agents
  • History of neuropathy
  • History of carpal tunnel syndrome
  • Allergic reactions to latex or gloves
  • Receiving treatments for neuropathy like amitriptyline, gabapentin, Acetyl L-Carnitine, Ganglioside-monosialic acid, acupuncture, cryotherapy, or exercise therapy
  • History of Raynaud phenomenon
  • Wounds or large scars on hands
  • Pregnancy or breastfeeding
  • Poorly controlled diabetes with HbA1c greater than 6.5 percent or equivalent measurement

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 9 weeks

Participants wear surgical glove-compression therapy or non-compressive plastic gloves for 30 minutes before, during, and after chemotherapy to prevent peripheral neuropathy.

Visits at weeks 0, 3, 6, and 9 during chemotherapy treatment

Trial Site Locations

Total: 1 location

1

Rajavithi Hospital, Medical Oncology Unit

Bangkok, Bangkok, Thailand, 10400

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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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