RadiodermatitisNCT03255980
Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®
A study testing Xonrid® gel in people with Radiodermatitis and Quality of Life, run by Helsinn Healthcare SA at 1 site in Italy.
Trial summary
To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiodermatitis, Quality of Life
- What is being tested?
- Xonrid® gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2017to 22 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female which are 18 years of age or older
- Performance status < 2
- Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands or breast cancer, planned to receive a total dose of at least 50 Gy
- Postoperative or curative radiation treatment
- Concurrent chemotherapy is accepted, in head \& neck cancer patients
- Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the Clinical Investigation Plan tests and procedures.
Who cannot join
- Pregnant or lactating women
- Planned to receive concurrent cetuximab
- Previous radiation therapy on the head and neck area or breast and thorax areas
- Cutaneous and connective diseases (i.e. lupus erythematosus or scleroderma)
- Systemic diseases known to delay the skin healing process such as diabetes mellitus or severe renal failure
- Use of a tissue-equivalent bolus
Show all 10Show fewer
- Use of over-the-counter topical medications containing steroids
- Presence of rashes or unhealed wounds in the radiation field
- Recent sun exposure
- Mental conditions that could adversely affect patients' adherence to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocenter, Open Label Clinical Investigation on the Treatment With Xonrid®, a Medical Device for the Prevention and Treatment of Radiotherapy-induced Dermatitis, in Breast and Head & Neck Cancer Patients Receiving Curative Treatment.
To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients.
Read the detailed description
The aim of this clinical investigation is to evaluate if the use of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients can be a valid support, when compared to the Standard of Care as defined by MASCC (Multinational Association for Supportive Care in Cancer) guidelines.
- Conditions
- Radiodermatitis, Quality of Life
- Being tested
- Xonrid® gel, Standard of Care
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xonrid® gelDevice
Water based gel for the management of toxicity skin symptoms induced by Radiotherapy
Standard of CareOther
Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines
| Study group | Role | What they receive |
|---|---|---|
| Xonrid® | Experimental | Xonrid® is a medical device for radiation dermatitis Receives: Device: Xonrid® gel; Other: Standard of Care |
| Standard of Care | Active comparator | Standard of care suggested by MASCC guidelines Receives: Device: Xonrid® gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5
The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis < G2) at week 5
Measured: 5 weeks over 7 weeks
Secondary outcomes (8)
Median Time to G2 Radiodermatitis Development
Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation
Measured: 5 weeks over 7 weeks
The Proportion of Patients Without G2 Radiation Dermatitis at Week 6 for Both Cancer Sites, at Week 7 for Head & Neck Cancer and 2 Weeks After the Last Radiation for Both Cancer Sites
Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans
Measured: 5 weeks over 7 weeks
The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation
Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation for both cancer sites, at week 7 for head \& neck cancer and 2 weeks after the last radiation for both cancer sites.
Measured: 6 weeks over 7 weeks
The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.
The changes in skin erythema and pigmentation, according to the ITA (individual Typological Angle) degrees measured throughout the study by the Investigators.
Measured: Follow-up: 2 weeks after the completion of radiation treatment
The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation
Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema
Measured: weekly during teratment (7 weeks)
The Mean and Worst Score of Skindex-16 Questionnaire
Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16
Measured: 5 weeks over 7 weeks
The Compliance to Experimental Treatment, Assessed Through the Number of Daily Product Applications Reported on the Patient's Diary, Compared to the Amount of Used Product
Compliance is based on the total amount ( weight) of Xonrid used over the treatment period
Measured: 5 weeks over 7 weeks
The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale
Global patient's satisfaction recorded by the Linkert Scale
Measured: 6 weeks over 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start15 Jun 2017
- Primary completion20 Feb 2019
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RadiodermatitisStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- MONOCENTER, OPEN LABEL CLINICAL INVESTIGATION
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Healthcare SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orlandi Ester, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255980
- Sponsor's protocol ID
- HD01-16-30
- Status last verified
- Jan 2020
- First submitted
- 6 Jul 2017
- Last updated
- 16 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocenter, Open Label Clinical Investigation on the Treatment With Xonrid®, a Medical Device for the Prevention and Treatment of Radiotherapy-induced Dermatitis, in Breast and Head & Neck Cancer Patients Receiving Curative Treatment.
- ClinicalTrials.gov ID
- NCT03255980
- Acronym / sponsor ID
- HD01-16-30
- Conditions
- Radiodermatitis, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Helsinn Healthcare SAIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Posted 16 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients.
Detailed description
The aim of this clinical investigation is to evaluate if the use of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients can be a valid support, when compared to the Standard of Care as defined by MASCC (Multinational Association for Supportive Care in Cancer) guidelines.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- MONOCENTER, OPEN LABEL CLINICAL INVESTIGATION
| Arm | Type | Receives |
|---|---|---|
| Xonrid® | Experimental | Device: Xonrid® gel, Other: Standard of CareXonrid® is a medical device for radiation dermatitis |
| Standard of Care | Active comparator | Device: Xonrid® gelStandard of care suggested by MASCC guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female which are 18 years of age or older
- Performance status < 2
- Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands or breast cancer, planned to receive a total dose of at least 50 Gy
- Postoperative or curative radiation treatment
- Concurrent chemotherapy is accepted, in head \& neck cancer patients
Key exclusion criteria (10 listed)
- Pregnant or lactating women
- Planned to receive concurrent cetuximab
- Previous radiation therapy on the head and neck area or breast and thorax areas
- Cutaneous and connective diseases (i.e. lupus erythematosus or scleroderma)
- Systemic diseases known to delay the skin healing process such as diabetes mellitus or severe renal failure
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 |
|---|---|---|
| Xonrid® gelWater based gel for the management of toxicity skin symptoms induced by Radiotherapy | Device | Standard of Care, Xonrid® |
| Standard of CareStandard of care suggested by MASCC' Skyn Toxicity Study Group guidelines | Other | Xonrid® |
Primary outcome
Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5
Time frame: 5 weeks over 7 weeks
The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis < G2) at week 5
8 secondary outcomes
Median Time to G2 Radiodermatitis Development
Time frame: 5 weeks over 7 weeks
The Proportion of Patients Without G2 Radiation Dermatitis at Week 6 for Both Cancer Sites, at Week 7 for Head & Neck Cancer and 2 Weeks After the Last Radiation for Both Cancer Sites
Time frame: 5 weeks over 7 weeks
The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation
Time frame: 6 weeks over 7 weeks
The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.
Time frame: Follow-up: 2 weeks after the completion of radiation treatment
The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation
Time frame: weekly during teratment (7 weeks)
The Mean and Worst Score of Skindex-16 Questionnaire
Time frame: 5 weeks over 7 weeks
The Compliance to Experimental Treatment, Assessed Through the Number of Daily Product Applications Reported on the Patient's Diary, Compared to the Amount of Used Product
Time frame: 5 weeks over 7 weeks
The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale
Time frame: 6 weeks over 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Orlandi Ester, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xonrid® gel in people with Radiodermatitis and Quality of Life, run by Helsinn Healthcare SA at 1 site in Italy.
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 6 inclusion and 10 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 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5 (time frame: 5 weeks over 7 weeks). 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 16 Dec 2020.