Clinical trial NCT06411093: Efficacy and Safety of Kinesiology Tape Wrapping for Paronychia Induced by Epidermal Growth Factor Receptor Inhibitors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paronychia
Epidermal Growth Factor Receptor Inhibitor
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the severity of pain by Numerical Rating Scale
timeFrame: Evaluated at week 1, 2, 4, 6, 8 and 12 after the initiation of intervention
measure: Change in the severity of paronychia by the scoring system for paronychia related to oncologic treatments (SPOT)
timeFrame: Evaluated at week 2, 4, 6, 8 and 12 after the initiation of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ting-Jung Hsu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.