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

NCT06411093 | Completed

• 1 other identifier: 202001747A3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Paronychia; Epidermal Growth Factor Receptor Inhibitor

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

A combination of Kinesiology tape wrapping and conventional treatment

EXPERIMENTAL

Patients in the intervention arm will receive Kinesiology tape wrapping to separate the nail plate from the inflamed periungual tissue in addition to conventional treatment. This intervention will be applied at outpatient visits or during hospitalization. If the Kinesiology tape falls off, patients can either replace it themselves or leave it off until the next outpatient visit or unexpected hospitalization.

Combination Product: Kinesiology tape wrapping; Drug: Conventional treatment including silver nitrate cauterization

Conventional treatment

ACTIVE COMPARATOR

Patients in this arm will receive management according to routine clinical practice, including chemical cauterization with silver nitrate, with or without topical antiseptics, topical steroids, topical beta-blockers, systemic steroids, and systemic antibiotics. The above treatment will be applied at outpatient visits or during hospitalization.

Drug: Conventional treatment including silver nitrate cauterization

Interventions

Kinesiology tape wrapping COMBINATION_PRODUCT

Place Kinesiology tape between the nail plate and the inflamed periungual granulation tissue in addition to conventional treatment for 3 months

Also known as: "NITTO"Medical Adhesive Tape (Non-Sterile)

A combination of Kinesiology tape wrapping and conventional treatment

Conventional treatment including silver nitrate cauterization DRUG

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

A combination of Kinesiology tape wrapping and conventional treatment; Conventional treatment

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Younger than 20 years
• severe ingrown nails
• concomitant cutaneous infection
• severe nail destruction
• chronic paronychia with severe periungual fibrosis

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Related 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.

  PMID: 35307912 BACKGROUND

MeSH Terms

Conditions

Paronychia

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ting-Jung Hsu, M.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: March 2, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

TW (1)