NCT06411093

Efficacy and Safety of Kinesiology Tape Wrapping for Paronychia Induced by Epidermal Growth Factor Receptor Inhibitors

A Single-center, Randomized, Open-labelled Trial to Evaluate the Efficacy and Safety of the Kinesiology Tape for the Treatment of Paronychia Induced by Epidermal Growth Factor Receptor Inhibitors in Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Epidermal growth factor receptor inhibitors(EGFRIs) have been applied in several common malignancies including advanced non-small cell lung cancer. Paronychia is one of the most common cutaneous side effects, characterized by inflamed granulation tissue around the nails leading to pain and reduced quality of life. Despite available conventional therapies such as topical beta-blockers or chemical cauterization, some patients still do not respond well. Our previous pilot study suggested that adding Kinesiology tape wrapping to the conventional treatment may effectively improve pain and granulomas in patients with treatment-resistant EGFRI-related paronychia, with good safety. This study aims to evaluate the clinical efficacy and safety of using Kinesiology tape wrapping as an adjunct to conventional therapy for patients with EGFRI-related paronychia.

Detailed description

In this study, eligible patients with paronychia affecting their big toes will be included and randomized to receive a combination of Kinesiology tape wrapping and conventional treatment, or conventional treatment alone for 3 months. Patients are evaluated at baseline, at 1, 2, 4, 8, and 12 weeks after the initiation of the treatment. These evaluations will occur at the outpatient department or through phone contact and photos taken by patients if they cannot visit in person. Efficacy endpoints include pain numerical rating scale (NRS) and scoring system for paronychia related to oncologic treatments (SPOT). Besides, any side effects will be recorded at each visit.

Conditions

• Paronychia
• Epidermal Growth Factor Receptor Inhibitor

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Kinesiology tape wrapping	Place Kinesiology tape between the nail plate and the inflamed periungual granulation tissue in addition to conventional treatment for 3 months
DRUG	Conventional treatment including silver nitrate cauterization	Conventional treatment including silver nitrate cauterization, with or without topical antiseptics, topical steroids, topical beta-blockers, short-term systemic antibiotics, systemic steroids for 3 months

Timeline

• Start date: 2023-03-02
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2024-05-13
• Last updated: 2024-05-13

Locations

1 site across 1 country: Taiwan