Mepitel Film Breast
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-100
SponsorNational University Hospital, Singapore
About this trial
Primary Objective To examine the tolerability of Mepitel Film in the prevention of RD patients undergoing whole breast or chest wall RT in the hot and humid weather in Singapore
Secondary Objectives To evaluate the incidence of acute radiation dermatitis, quality of life, satisfaction, and cost analysis of Mepitel Film use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 21 years old (legal age of maturity in Singapore)
Male or female
Informed consent
Patients have undergone a mastectomy with or without reconstruction or breast-conserving surgery.
Disqualifiers
Prior RT to any portion of the planned treatment site.
Patients will receive partial breast external beam RT, proton beam therapy, or brachytherapy.
Patients with active rash, pre-existing dermatitis, or other conditions within the treatment area may make skin assessment for the study difficult per treating physician discretion.
Known history of adhesive, tape or silicon allergy or sensitivity.
Trial population
National University Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Patients with breast radiation
Group B: Patients with chest wall radiation
Trial outcomes
Primary outcomes
1
Frequency of total replacement of Mepitel Film or "touch-up" when compared with the data from the RCT in Ontario, Canada
Time frame
From first day RT to the 2 weeks post RTSecondary outcomes
1
Frequency and severity of patient reported pruritis in SSA and RISRAS related to use of Mepitel Film when compared with the data from the RCT in Ontario, Canada
Time frame
From enrollment to the 3 months post RT2
Incidence of ARD grades 2 to 3, as defined by the CTCAE V5 assessed by HCP
Time frame
From enrollment to the 2 weeks post RT3
Patient-reported skin-related symptoms using the Skin Symptom Assessment (SSA)
Time frame
From enrollment to the end of study (2 years post RT)4
HCP reported SSA
Time frame
From enrollment to the end of study (2 years post RT)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National University Hospital, Singapore
Lead sponsor
Molnlycke Health Care AB
Collaborator
Source ClinicalTrials.gov