MedTrace Logo

Patient Reported Outcomes Using Mepitel Film During Radiotherapy

NCT06133218 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-11-15

No results posted yet for this study

Summary

Breast cancer patients in post-operative radiotherapy (RT) often experience acute skin reactions like erythema, pain, itching and oversensitivity. In 2014 a New Zealand randomized controlled trial (RCT) investigated the prophylactic use of safetac-based film, Mepitel Film, on half of the breast during RT compared to cream, resulting in significant differences in skin moist desquamation (0% vs. 26%). Despite changes in treatment modalities in Denmark toward lower total RT doses, the level of RT-induced skin toxicity could still be of great importance for the patients. The aim of this study is patient-reported symptoms and patient-reported experiences with the prophylactic use of Mepitel Film compared to standard cream treatment.

Conditions

  • Radiodermatitis
  • Breast Neoplasms
  • Side Effect

Interventions

OTHER

Mepitel Film

A safetac-based barrier film with a clinically insignificant bolus effect to protect the skin during radiotherapy.

Sponsors & Collaborators

  • Herning Hospital

    collaborator OTHER

  • Vejle Hospital

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Pia K Moeller, MPH · Odense University Hospital (OUH)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
125 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2016-02-29
Completion
2016-02-29

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06133218 on ClinicalTrials.gov