Head and Neck CancerNCT02261181
Preemptive Treatment With XONRID to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients
A study testing XONRID in people with Head and Neck Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
There is a strong need to study products with a preemptive role in radiation dermatitis development, with a trial design taking in account patient subjective evaluation and compliance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- XONRID
- 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
- Jan 2015to Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years
- Performance status < 2
- Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands
- Planned to receive at least 50 Gy on one side of the neck with at least the 2nd level of neck nodes irradiated
- Postoperative or curative radiation treatment
- Concurrent platinum based chemotherapy is accepted, but not mandatory
- Conventional fractionation (1.8-2.12 GY per fraction, one daily fraction, 5 fractions a week )
Who cannot join
- Pregnant or lactating women
- Planned to receive concurrent cetuximab
- Previous radiation therapy on the head and neck area
- Cutaneous and connettive 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: Preemptive Treatment With XONRID a Medical Device to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients Receiving Curative Treatment
There is a strong need to study products with a preemptive role in radiation dermatitis development, with a trial design taking in account patient subjective evaluation and compliance.
XONRID is a promising device for radiation high grade dermatitis prevention; it is a topical gel that prevents and treats skin symptoms such as erythema, itching, burning sensation and pruritus, induced by radiotherapy or other causes.
Read the detailed description
The patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients in the Institution.
Patients will be planned to receive Intensity-Modulated Radiotherapy Techniques (IMRT or volumetric modulated radiotherapy, VMAT) with conventional fractionation at total dose of 50-66 GY in postoperative setting and 66-70 Gy in radical setting. Radiotherapy will be planned with simultaneous boost (SIB) approaches, using conventional fractionation (1.8-2.12 Gy/die). According to histology, stage and pathology reports, patients could receive concomitant platinum based chemotherapy.
The patients will be evaluated at baseline, at weekly intervals during RT and six months after treatment completion by 2 different treating physicians for each visit. The evaluation will consist of a physician-assessed toxicity assessment using the Radiation Therapy Oncology Group (RTOG), and patient-reported outcome measured using the Skindex-16 questionnaire.
In addition objective in vivo measurements of skin erythema and pigmentation based on reflectance spectrometry (RS) will be performed.
Measurements will be performed before RT, every 5 RT fractions (once a week) up to the end of RT and 6 months after RT completion (same timing as clinical evaluation). Instrumental RS measurement will be performed at five different fixed regions within the area treated with RT, in any cases only on flat skin regions of the neck in an area corresponding to the second node level and in absence of hair or nevus.
- Conditions
- Head and Neck Cancer
- Being tested
- XONRID
- Keywords
- head neck cancer XONRID radiation induced dermatitis
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XONRIDDevice
The patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients. Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines.
| Study group | Role | What they receive |
|---|---|---|
| XONRID | Experimental | Patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients.
Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines. The use of other topical medications for the treatment of dermatitis will be not permitted during the study. Receives: Device: XONRID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst skin toxicity
Worst skin toxicity during treatment and until 2 weeks after according to CTCAE , as assessed independently by 2 physicians
Measured: 14 months
Secondary outcomes (4)
MeanPatient Reported Outcome (PRO)
Mean and worst score (measured on a numeric 0-6 scale, where 0= absence of symptom and 6= worst intensity of symptom) of Patient Reported Outcome (PRO) with Skindex 16 questionnaire performed weekly until reaching a total dose of 50 Gy on neck
Measured: 14 months
Median time to G2 radiation dermatitis development
Median time to G2 radiation dermatitis development according to CTCAE
Measured: 14 months
Compliance
Compliance to experimental treatment assumption considering a complete cpmpliance from 0 to 2 applications skipped, a partial compiance from 3 to 10 applications skipped and an absent compliance from 11 to 14 applications skipped.
Measured: 14 months
Grade of late toxicity
Grade of late toxicity (skin fibrosis according to CTCAE) at 6 month follow up visit after treatment ending
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ester Orlandi, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261181
- Sponsor's protocol ID
- INT 52/14
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2014
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Ingargiola R, De Santis MC, Iacovelli NA, Facchinetti N, Cavallo A, Ivaldi E, Dispinzieri M, Franceschini M, Giandini C, Romanello DA, Di Biaso S, Sabetti M, Locati L, Alfieri S, Bossi P, Guglielmo M, Macchi F, Lozza L, Valdagni R, Fallai C, Pignoli E, Orlandi E. A monocentric, open-label randomized standard-of-care controlled study of XONRID(R), a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients. Radiat Oncol. 2020 Aug 13;15(1):193. doi: 10.1186/s13014-020-01633-0.
PubMed 32791985
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Treatment With XONRID a Medical Device to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients Receiving Curative Treatment
- ClinicalTrials.gov ID
- NCT02261181
- Acronym / sponsor ID
- INT 52/14
- Conditions
- Head and Neck Cancer
- Keywords
- head neck cancer XONRID radiation induced dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 10 Oct 2014 (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.
There is a strong need to study products with a preemptive role in radiation dermatitis development, with a trial design taking in account patient subjective evaluation and compliance.
XONRID is a promising device for radiation high grade dermatitis prevention; it is a topical gel that prevents and treats skin symptoms such as erythema, itching, burning sensation and pruritus, induced by radiotherapy or other causes.
Detailed description
The patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients in the Institution.
Patients will be planned to receive Intensity-Modulated Radiotherapy Techniques (IMRT or volumetric modulated radiotherapy, VMAT) with conventional fractionation at total dose of 50-66 GY in postoperative setting and 66-70 Gy in radical setting. Radiotherapy will be planned with simultaneous boost (SIB) approaches, using conventional fractionation (1.8-2.12 Gy/die). According to histology, stage and pathology reports, patients could receive concomitant platinum based chemotherapy.
The patients will be evaluated at baseline, at weekly intervals during RT and six months after treatment completion by 2 different treating physicians for each visit. The evaluation will consist of a physician-assessed toxicity assessment using the Radiation Therapy Oncology Group (RTOG), and patient-reported outcome measured using the Skindex-16 questionnaire.
In addition objective in vivo measurements of skin erythema and pigmentation based on reflectance spectrometry (RS) will be performed.
Measurements will be performed before RT, every 5 RT fractions (once a week) up to the end of RT and 6 months after RT completion (same timing as clinical evaluation). Instrumental RS measurement will be performed at five different fixed regions within the area treated with RT, in any cases only on flat skin regions of the neck in an area corresponding to the second node level and in absence of hair or nevus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XONRID | Experimental | Device: XONRIDPatients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients. Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines. The use of other topical medications for the treatment of dermatitis will be not permitted during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- > 18 years
- Performance status < 2
- Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands
- Planned to receive at least 50 Gy on one side of the neck with at least the 2nd level of neck nodes irradiated
- Postoperative or curative radiation treatment
Key exclusion criteria (10 listed)
- Pregnant or lactating women
- Planned to receive concurrent cetuximab
- Previous radiation therapy on the head and neck area
- Cutaneous and connettive 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 |
|---|---|---|
| XONRIDThe patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients. Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines. | Device | XONRID |
Primary outcome
Worst skin toxicity
Time frame: 14 months
Worst skin toxicity during treatment and until 2 weeks after according to CTCAE , as assessed independently by 2 physicians
4 secondary outcomes
MeanPatient Reported Outcome (PRO)
Time frame: 14 months
Median time to G2 radiation dermatitis development
Time frame: 14 months
Compliance
Time frame: 14 months
Grade of late toxicity
Time frame: 14 months
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 29 Sep 2021.
- Derived from this study: PubMed 32791985Ingargiola R, De Santis MC, Iacovelli NA, Facchinetti N, Cavallo A, Ivaldi E, Dispinzieri M, Franceschini M, Giandini C, Romanello DA, Di Biaso S, Sabetti M, Locati L, Alfieri S, Bossi P, Guglielmo M, Macchi F, Lozza L, Valdagni R, Fallai C, Pignoli E, Orlandi E. A monocentric, open-label randomized standard-of-care controlled study of XONRID(R), a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients. Radiat Oncol. 2020 Aug 13;15(1):193. doi: 10.1186/s13014-020-01633-0.
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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.
Ester Orlandi, 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 in people with Head and Neck Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 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 7 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 29 Sep 2021. 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?
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?
Worst skin toxicity (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02261181, which also lists 1 linked publication.
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 29 Sep 2021.