Status:

COMPLETED

Patient Reported Outcomes Using Mepitel Film During Radiotherapy

Lead Sponsor:

Odense University Hospital

Collaborating Sponsors:

Herning Hospital

Vejle Hospital

Conditions:

Radiodermatitis

Breast Neoplasms

Eligibility:

FEMALE

18-125 years

Phase:

NA

Brief 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 (RC...

Detailed Description

Aim: The use of Mepitel Film in the RCT from New Zealand resulted in significant differences in the acute morbidity of the skin. However, the clinical experience in Denmark with the new RT treatment ...

Eligibility Criteria

Inclusion

  • All women referred to postoperative adjuvant radiotherapy for breast cancer from October 1st 2015 to February 29th 2016 at the three radiotherapy departments.
  • Who read and understand Danish
  • Patients must have signed and dated a written informed consent form in accordance with regulatory and institutional guidelines.
  • Patients must be willing and able to comply the questionnaires and attend a two-week follow-up posttreatment.

Exclusion

  • Patients included in the ongoing Danish HYPO PBI protocol (hypofractionated partial breast irradiation)

Key Trial Info

Start Date :

October 1 2015

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 29 2016

Estimated Enrollment :

101 Patients enrolled

Trial Details

Trial ID

NCT06133218

Start Date

October 1 2015

End Date

February 29 2016

Last Update

November 15 2023

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