Post-surgery RadiotherapyPhase 3NCT02741258
Mepitel Film Treatment for the Prevention and Cutaneous Toxicity Due to Radiotherapy
A Phase 3 study testing Mepitel Film and skin cream in people with Post-surgery Radiotherapy, run by Dario Valcarenghi at 2 sites in Switzerland.
Trial summary
This is a randomized study, mepitel vs standard of care for the prevention and skin toxicity due to radiotherapy in patients with post-surgery breast cancer. Mepitel film will be placed on the skin of the patients just before the start of the radiotherapy and will be replaced once a week until the end of the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-surgery Radiotherapy
- What is being tested?
- Mepitel Film and skin cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Oct 2015to 31 Dec 2021
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with breast cancer treated with conservative surgery who need radiotherapy treatment
- capability and willness to participate to the study
- informed consent form signature
Who cannot join
- contraindication to the correct placement of the Mepitel Film
- previous breast radiation treatment
- participating in other clinical trials
- previous breast reconstruction
- concomitant treatment with antiblastic chemotherapy
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Oncology Institute of Southern Switzerland
Bellinzona, 6500
Institut für Radiotherapie Klinik Hirslanden
Zurich, 8032
About this study
Official title: Mepitel Film vs Standard of Care for the Radiotherapy Prevention and Cutaneous Toxicity in Patients With Post-surgery Breast Cancer
This is a randomized study, mepitel vs standard of care for the prevention and skin toxicity due to radiotherapy in patients with post-surgery breast cancer.
Mepitel film will be placed on the skin of the patients just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of toxicities.
Read the detailed description
For patients randomized in the mepitel arm:
Mepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with mepitel.
For patients randomized in the standard of treatment arm:
Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine o Ialugen Plus) cream in case of skin erythema. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment.
- Conditions
- Post-surgery Radiotherapy
- Being tested
- Mepitel Film, skin cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepitel FilmDevice
Placement of Mepitel Film to prevent skin toxicity
skin creamDrug
Also called Excipial U hydrolotion, Flammazin
cream to treat skin erythema due to radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Mepitel Film | Experimental | Mepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with Mepitel. Receives: Device: Mepitel Film |
| Excipial U hydrolotion, Flammazin skin cream | Active comparator | Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine or Ialugen Plus) cream in case of skin erythema due to radiotherapy. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment. Receives: Drug: skin cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mepitel Film efficacy in treating skin toxicity evaluatet with Common Terminology Criteria for Adverse Events (CTCAE)
Common Terminology Criteria for Adverse Events (CTCAE) V.4 will be used to evaluate the toxicity
Measured: one week after start of radiotherapy
Secondary outcomes (2)
Time for the skin toxicity appearance and resolution
Measured: one week after start of radiotherapy
Severity of the chronic skin toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v.4
Measured: one week after start of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study start1 Oct 2015
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-surgery RadiotherapyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dario Valcarenghi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dario Valcarenghi, Oncology Institute of Southern Switzerland
- Investigators
- Dario Valcarenghi, Study chair, Oncology Institute of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741258
- Sponsor's protocol ID
- IOSI-INF-001
- Status last verified
- Jun 2022
- First submitted
- 15 Mar 2016
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: not foreseen
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mepitel Film vs Standard of Care for the Radiotherapy Prevention and Cutaneous Toxicity in Patients With Post-surgery Breast Cancer
- ClinicalTrials.gov ID
- NCT02741258
- Acronym / sponsor ID
- IOSI-INF-001
- Conditions
- Post-surgery Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Dario ValcarenghiUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Apr 2016 (estimated)
- 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.
This is a randomized study, mepitel vs standard of care for the prevention and skin toxicity due to radiotherapy in patients with post-surgery breast cancer.
Mepitel film will be placed on the skin of the patients just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of toxicities.
Detailed description
For patients randomized in the mepitel arm:
Mepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with mepitel.
For patients randomized in the standard of treatment arm:
Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine o Ialugen Plus) cream in case of skin erythema. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepitel Film | Experimental | Device: Mepitel FilmMepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with Mepitel. |
| Excipial U hydrolotion, Flammazin skin cream | Active comparator | Drug: skin creamPatients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine or Ialugen Plus) cream in case of skin erythema due to radiotherapy. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with breast cancer treated with conservative surgery who need radiotherapy treatment
- capability and willness to participate to the study
- informed consent form signature
Key exclusion criteria (5 listed)
- contraindication to the correct placement of the Mepitel Film
- previous breast radiation treatment
- participating in other clinical trials
- previous breast reconstruction
- concomitant treatment with antiblastic chemotherapy
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 FilmPlacement of Mepitel Film to prevent skin toxicity | Device | Mepitel Film |
| skin creamAlso: Excipial U hydrolotion, Flammazincream to treat skin erythema due to radiotherapy | Drug | Excipial U hydrolotion, Flammazin skin cream |
Primary outcome
Mepitel Film efficacy in treating skin toxicity evaluatet with Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: one week after start of radiotherapy
Common Terminology Criteria for Adverse Events (CTCAE) V.4 will be used to evaluate the toxicity
2 secondary outcomes
Time for the skin toxicity appearance and resolution
Time frame: one week after start of radiotherapy
Severity of the chronic skin toxicity
Time frame: one week after start of radiotherapy
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 5 Jul 2022.
- Individual participant dataSharing planned: No. not foreseen
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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.
Dario Valcarenghi study chair
Oncology Institute of Southern Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mepitel Film and skin cream in people with Post-surgery Radiotherapy, run by Dario Valcarenghi at 2 sites in Switzerland.
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 3 inclusion and 5 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 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mepitel Film efficacy in treating skin toxicity evaluatet with Common Terminology Criteria for Adverse Events (CTCAE) (time frame: one week after start of radiotherapy). 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 5 Jul 2022.