Education Intervention in Patients with Rash Due to Epidermal Growth Factor Receptor (EGFR) Treatment.

NCT03992664 | Completed DMC

• 1 other identifier: 0000-0001-5580-7256
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The main adverse reaction of EGFR seen in patients is rash. EGFR treated patients have a 24-95% incidence of rash depending on the type of treatment they receive. Skin toxicity may occur in more than 80% of patients treated with cetuximab. If a severe rash (Grade 3 or 4) occurs, a dose reduction or discontinuation of treatment may be required. Also, infections are the main secondary side effect caused by the rash. The aim of the study is through a randomized clinical trial feasibility study to investigate the effectiveness of an educational intervention in patients receiving EGFRI therapy. It will be randomly selected which patients will belong to the intervention group and who in the control group. The type of program involves educational intervention.

Conditions

Consent Form; Lung Cancer; Colon Cancer; Pancreas Cancer; Head and Neck Cancer; Breast Cancer

Keywords

rash, photosensitivity, pruritus, educational, chemotherapy, EGFRI, immunotherapy

Outcome Measures

Primary Outcomes (1)

• Skin grades

  Repeated measurements were taken weekly regarding the grade of rash, pruritus and photosensitivity.

  4 weeks

Secondary Outcomes (1)

• Functional health and wellbeing status

  4 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

The patients in the experimental group follow the educational program once weekly, for 4 weeks.

Other: Educational training program

NON-INTERVENTION

NO INTERVENTION

The usual information was provided to them

Interventions

Educational training program OTHER

The training program will focus on four parameters: cleanliness, hydration, protection from external stimuli, and finally early detection of skin side effects. The re-evaluation of the skin as well as the repetition of the questionnaires will be done every week for 4 weeks.

Experimental

Eligibility Criteria

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

1. Adult cancer patients (\>18). 2. Patients who suffered with pruritus, or rash or photosensitivity, in the onset of the symptoms. 3. Willing to participate. 4. Ability to complete the questionnaires. 5. A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG). 6. Patients with no pre-existing dermatological condition that may limit the interpretation of results.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cyprus University of Technology: lead

Study Sites (1)

Eleni Papoui

Larnaca, ATHIENOU, 7600, Cyprus

Location

MeSH Terms

Conditions

Lung Neoplasms; Colonic Neoplasms; Pancreatic Neoplasms; Head and Neck Neoplasms; Breast Neoplasms; Exanthema; Photosensitivity Disorders; Pruritus

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ANDREAS CHARALAMBOUS, PhD

  Cyprus University of Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NURSE, PhD (C)

Study Record Dates

• First Submitted: June 15, 2019
• First Posted: June 20, 2019
• Study Start: January 1, 2019
• Primary Completion: December 12, 2020
• Study Completion: August 10, 2022
• Last Updated: February 13, 2025

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)