Patient Reported Outcomes Using Mepitel Film During Radiotherapy

NCT06133218 | Completed DMC

• 1 other identifier: OP_168
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

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 (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

Outcome Measures

Primary Outcomes (2)

• Patient-reported experience measures (PREM)

  Patient experiences and preferences regarding Mepitel film for women with breast cancer undergoing radiotherapy based on their own experience with skin toxicity. The PREM-questionnaire consisted of seven questions regarding comfort and preferences with a 4-point Likert scale (strongly agree, mildly agree, mildly disagree, strongly disagree).

  Two-week follow-up after RT

• Patient-reported outcome measures (PRO)

  The proportion of radiation-induced symptoms with or without film (pain, itching, burning sensation, edema, sensitive or flaky skin) and the effect on work/daily activities measured with a 4-Point Likert Scale (not at all, a little, some, a lot).

  Two-week follow-up after RT

Secondary Outcomes (2)

• Radiodermatitis

  Last 1 day of radiotherapy

• Radiodermatitis

  Two-week follow-up

Study Arms (2)

Intervention side - Mepitel Film

ACTIVE COMPARATOR

This was an intra-patient randomized study. The patient was randomized for Mepitel film (barrier film) applied on the medial or lateral side of their breast or chest wall during the entire course of radiotherapy; making the patients their own control.

Other: Mepitel Film

Control side - standard care

NO INTERVENTION

The other side of the breast or chest wall is the intra-patient control as the skin on this side was treated according to standard guidelines for skin care during radiotherapy when symptoms or skin reactions occured.

Interventions

Mepitel Film OTHER

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

Intervention side - Mepitel Film

Eligibility Criteria

• Age: 18 Years - 125 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Odense University Hospital: lead
• Herning Hospital: collaborator
• Vejle Hospital: collaborator

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases

Study Officials

• Pia K Moeller, MPH

  Odense University Hospital (OUH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse Specialist, MPH

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: November 15, 2023
• Study Start: October 1, 2015
• Primary Completion: February 29, 2016
• Study Completion: February 29, 2016
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share