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

Paronychia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06411093
• Other study ID #: 202001747A3
• Status: Completed
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

• EGFR inhibitors-induced paronychia

• Having at least one big toe involved with CTCAE(Common Terminology Criteria for Adverse Events) grade 2-3 paronychia

Exclusion Criteria:

• Younger than 20 years

• severe ingrown nails

• concomitant cutaneous infection

• severe nail destruction

• chronic paronychia with severe periungual fibrosis

Related Conditions & MeSH terms

• Epidermal Growth Factor Receptor Inhibitor
• Paronychia

Intervention

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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Hsu TJ, Yeh HH, Liu KL. Kinesiology tapes wrapping for paronychia induced by epidermal growth factor receptor inhibitors: A pilot study. Dermatol Ther. 2022 Jun;35(6):e15463. doi: 10.1111/dth.15463. Epub 2022 Mar 29. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the severity of pain by Numerical Rating Scale	Patients rate the severity of pain over the tender point of the affected big toe on a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable.	Evaluated at week 1, 2, 4, 6, 8 and 12 after the initiation of intervention
Primary	Change in the severity of paronychia by the scoring system for paronychia related to oncologic treatments (SPOT)	The SPOT evaluates the severity of the affected big toe based on four parameters, including redness, edema, discharge and granulation tissue, each measured on a 4-point scale from 0 to 3 with 0 for no presence of signs and 3 for most severe of lesions. The total score ranges from 0 to 12.	Evaluated at week 2, 4, 6, 8 and 12 after the initiation of intervention