Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06133218 |
Other study ID # |
OP_168 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 1, 2015 |
Est. completion date |
February 29, 2016 |
Study information
Verified date |
November 2023 |
Source |
Odense University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 modalities for breast cancer patients with lower total doses and less treatment
fractions indicate less severe skin toxicity than the old treatment modalities.
The primary endpoint of this study is to investigate if prophylactic use of Mepitel Film to
prevent severe skin reactions makes a difference for the patient experience of their RT
induced skin reactions compared to treating the symptoms when they appear according to
present clinical guidelines. Additional to the patient-reported experiences with the
prophylactic use of Mepitel Film, the patients are asked to report their acute symptoms from
the skin in the area with or without Mepitel Film at the end of treatment and two weeks after
treatment. A secondary endpoint was a blinded radiotherapy staff evaluation of dermatitis.
Method:
The study was a multicenter trial with participation of three Danish hospitals: Aarhus
University Hospital (Herning site), Vejle Hospital, and Odense University Hospital.
For all patients either the lateral or medial part of the treatment area was covered by film
based on a randomization; making the patients their own control.
The randomization procedure was conducted by assigned radiotherapists (RTTs) at each hospital
in the online system RedCap (Research Electronic Data Capture) provided by Odense Patient
Data Explorative Network (OPEN). A block randomization was conducted stratifying for hospital
to balance at each institution the number of patients having film applied at the medial or
lateral part of the chest.
A questionnaire was developed.consisting of four sections. Two sections with patient-reported
outcome measures (PROM) regarding skin symptoms. Furthermore, a section with patient-reported
experience measures (PREM) related to the use and preference of the barrier film and finally
a section for staff evaluation of dermatitis.
The PROM-questionnaire was developed guided by existing validated questionnaires
(RISRAS-scale [14], and the breast cancer specific EORTC-questionnaire [15]). The answers
were categorized on a 4-Point Likert Scale (not at all, a little, some, a lot).
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) and a
scale for grading overall health and overall QOL. The questionnaires were cognitively
validated by 3 patients.
The patients were asked to fill out the paper-based questionnaire on the day of their final
radiotherapy treatment and a similar one at the two week follow-up.