RadiodermatitisNCT06133218
Patient Reported Outcomes Using Mepitel Film During Radiotherapy
A study testing Mepitel Film in people with Radiodermatitis and Breast Neoplasms, run by Odense University Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 125 years, women only
- Conditions the study is for
- Radiodermatitis, Breast Neoplasms, Side Effect
- What is being tested?
- Mepitel Film
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 29 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 125 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients included in the ongoing Danish HYPO PBI protocol (hypofractionated partial breast irradiation)
About this study
Official title: Patient-reported Experience and Symptom Measures on Prophylactic Use of Mepitel Film During Post-operative Breast Irradiation - a Danish Intra-patient Randomized Multicentre Study
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.
Read the 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 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.
- Conditions
- Radiodermatitis, Breast Neoplasms, Side Effect
- Being tested
- Mepitel Film
- Medical subject headings
- Radiodermatitis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepitel FilmOther
A safetac-based barrier film with a clinically insignificant bolus effect to protect the skin during radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Two-week follow-up after RT
Secondary outcomes (2)
Radiodermatitis
The grade of radiodermatitis (RTOG-scale)on the chest side with Mepitel Film vs the skin area treated according to standard care. A blinded evaluation.
Measured: Last 1 day of radiotherapy
Radiodermatitis
The grade of radiodermatitis (RTOG-scale)on the chest side with Mepitel Film vs the skin area treated according to standard care. A blinded evaluation.
Measured: Two-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start1 Oct 2015
- Primary completion29 Feb 2016
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiodermatitisStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herning Hospital, Vejle Hospital
- Responsible party
- Principal investigator, Pia Krause Møller, Odense University Hospital
- Investigators
- Pia K Moeller, MPH, Principal investigator, Odense University Hospital (OUH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133218
- Sponsor's protocol ID
- OP_168
- Status last verified
- Nov 2023
- First submitted
- 26 Mar 2018
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Experience and Symptom Measures on Prophylactic Use of Mepitel Film During Post-operative Breast Irradiation - a Danish Intra-patient Randomized Multicentre Study
- ClinicalTrials.gov ID
- NCT06133218
- Acronym / sponsor ID
- OP_168
- Conditions
- Radiodermatitis, Breast Neoplasms, Side Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Herning Hospital, Vejle Hospital
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention side - Mepitel Film | Active comparator | Other: Mepitel FilmThis 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. |
| 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. |
Who may qualify
- Ages
- 18 to 125 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients included in the ongoing Danish HYPO PBI protocol (hypofractionated partial breast irradiation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepitel FilmA safetac-based barrier film with a clinically insignificant bolus effect to protect the skin during radiotherapy. | Other | Intervention side - Mepitel Film |
Primary outcome
Patient-reported experience measures (PREM)
Time frame: Two-week follow-up after RT
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).
Patient-reported outcome measures (PRO)
Time frame: Two-week follow-up after RT
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).
2 secondary outcomes
Radiodermatitis
Time frame: Last 1 day of radiotherapy
Radiodermatitis
Time frame: Two-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Radiodermatitis
RecruitingPhase 2
A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy
Breast Cancer, Breast Cancer Female
RecruitingObservational study
Collecting Patient-Reported Experiences With Radiation Dermatitis in Breast Cancer Patients Undergoing Radiotherapy
Breast Carcinoma
RecruitingPhase 2
Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer
Radiation-induced Dermatitis
Not yet recruiting
Artificial Intelligence Powered Digital Education Based on the Neuman Systems Model for Breast Cancer Patients Receiving Radiotherap
Breast Cancer, Radiodermatitis
Not yet recruitingObservational study
Determinants of Radiation Dermatitis in Head and Neck Cancer Patients Receiving Preventive Photobiomodulation
Head and Neck Neoplasms, Radiodermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pia K Moeller, MPH principal investigator
Odense University Hospital (OUH)
Questions about this trial
What is this clinical trial studying?
A study testing Mepitel Film in people with Radiodermatitis and Breast Neoplasms, run by Odense University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported experience measures (PREM) (time frame: Two-week follow-up after RT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.