Head and Neck CancersNCT03394417
StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients
A study testing StrataXRT in people with Head and Neck Cancers and Acute Radiation Dermatitis, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This is a phase IV, prospective, double-blind, randomized controlled trial with 2 study arms. The study population will be patients receiving chemoradiation for head and neck carcinomas, the majority of whom will be outpatients unless they require inpatient supportive care during treatment. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Head and Neck Cancers, Acute Radiation Dermatitis
- What is being tested?
- StrataXRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Nov 2018to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are 21 years of age or older
- histological diagnosis of head and neck carcinoma available
- patients who are to be treated with concurrent chemoradiation
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- no known allergy to StrataXRT or silicone
- able to give written informed consent, or have written consent given on their behalf
Who cannot join
- patients who cannot apply the skin product or have it administered to them
- patients with comorbidities and/or on medications that may alter the response of the skin e.g. connective tissue disorder
- patients with existing rashes or wounds in the radiation field at baseline
- patients receiving concurrent cetuximab during radiotherapy
- previous radiotherapy to the head and neck region
- female patients who are pregnant or breast feeding
- unable to give written informed consent , or are unable to have written consent given on their behalf
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
About this study
Official title: StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Patients Receiving Concurrent Chemoradiation for Head and Neck Cancers
This is a phase IV, prospective, double-blind, randomized controlled trial with 2 study arms. The study population will be patients receiving chemoradiation for head and neck carcinomas, the majority of whom will be outpatients unless they require inpatient supportive care during treatment.
There will be a 12 to 14-week longitudinal follow-up with 9 assessments conducted during this follow-up.
Read more
The estimated duration of recruitment will be 6-8 years.
Intervention group If a patient is allocated to the intervention group following randomization, the patient will be treated with StrataXRT.
Control group If a patient is allocated to the control group following randomization, the patient will be treated with standard clinical practice which consists of aqueous cream.
Read the detailed description
Clinical significance and current evidence:
Radiation dermatitis occurs commonly in patients receiving chemoradiation for nasopharyngeal cancer; 50 to 60% develop grade 2 or higher dermatitis. This can result in significant morbidity, reduced aesthetic appearance, decrease in quality of life and delays in treatment. Current literature does not conclusively support the use of one agent over another for prevention of radiation dermatitis. The choice of agents used in clinical practice is highly variable, with aqueous agents being one of the commonest.
Specific Aims:
The aim of this study is to evaluate if the investigational product (StrataXRT), a silicone-based gel, is superior to standard clinical practice in prevention of grade 2 or higher acute dermatitis in patients receiving chemoradiation for nasopharyngeal carcinoma.
Trial Design:
The study will be conducted using a prospective, double-blind randomized control trial in 2 institutions. Each arm will receive standard radiation to a total dose of 70 Gray (Gy) with concurrent chemotherapy. The primary objective is to compare the prevention of dermatitis and the primary endpoint is reached when grade 2 or higher dermatitis according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale occurs. Secondary objectives will be evaluation of the time to onset of dermatitis, the time to complete recovery from dermatitis and the degree of pain. Assessment of the patient's skin will be done at baseline, weekly during treatment, 1 week post treatment and unless the skin has resolved to baseline then every week up until 6 weeks post-treatment, which will mark the end of follow-up. The safety end-point is reached when grade 4 dermatitis occurs.
Hypothesis and statistics:
The investigators aim to demonstrate a 30% reduction in the incidence of grade 2 or higher dermatitis with StrataXRT. Using a 2-sided test at significance level 0.05 to detect the difference with a power of 80%, the investigators envisage a recruitment of 100-150 patients in total. The study duration is estimated to be 8 years.
- Conditions
- Head and Neck Cancers, Acute Radiation Dermatitis
- Being tested
- StrataXRT
- 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.
StrataXRTDevice
randomized patient allocated to this group will receive StrataXRT for application during the treatment and 4 weeks further after the treatment ends.
| Study group | Role | What they receive |
|---|---|---|
| standard clinical practice (control) | No intervention | aqueous cream normally prescribed by radiation oncologists |
| StrataXRT (intervention) | Active comparator | silicon-based gel for radiation dermatitis Receives: Device: StrataXRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
grade 2 acute radiation dermatitis
when patient develops grade 2 acute radiation dermatitis as scored by Common Terminology Criteria for Adverse Event (CTCAE) version 4.03 scale with grade 1 the mildest, Grade 1: faint erythema or dry desquamation Grade 2: moderate to brisk erythema; patchy moist desquamation; moderate edema Grade 3: moist desquamation other than skin folds and creases; bleeding induced by minor trauma or abrasion Grade 4: skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site Grade 5: death
Measured: 10 weeks
Secondary outcomes (1)
completion of scheduled post-treatment assessment at 6 weeks post-radiotherapy
when patient completed the scheduled post-radiotherapy assessment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start8 Nov 2018
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancersStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Chia, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394417
- Sponsor's protocol ID
- 2016/01084
- Other IDs
- 2016
- Status last verified
- Dec 2024
- First submitted
- 3 Jan 2018
- Last updated
- 12 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Patients Receiving Concurrent Chemoradiation for Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT03394417
- Acronym / sponsor ID
- 2016/01084
- Conditions
- Head and Neck Cancers, Acute Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Jan 2018 (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.
This is a phase IV, prospective, double-blind, randomized controlled trial with 2 study arms. The study population will be patients receiving chemoradiation for head and neck carcinomas, the majority of whom will be outpatients unless they require inpatient supportive care during treatment.
There will be a 12 to 14-week longitudinal follow-up with 9 assessments conducted during this follow-up.
The estimated duration of recruitment will be 6-8 years.
Intervention group If a patient is allocated to the intervention group following randomization, the patient will be treated with StrataXRT.
Control group If a patient is allocated to the control group following randomization, the patient will be treated with standard clinical practice which consists of aqueous cream.
Detailed description
Clinical significance and current evidence:
Radiation dermatitis occurs commonly in patients receiving chemoradiation for nasopharyngeal cancer; 50 to 60% develop grade 2 or higher dermatitis. This can result in significant morbidity, reduced aesthetic appearance, decrease in quality of life and delays in treatment. Current literature does not conclusively support the use of one agent over another for prevention of radiation dermatitis. The choice of agents used in clinical practice is highly variable, with aqueous agents being one of the commonest.
Specific Aims:
The aim of this study is to evaluate if the investigational product (StrataXRT), a silicone-based gel, is superior to standard clinical practice in prevention of grade 2 or higher acute dermatitis in patients receiving chemoradiation for nasopharyngeal carcinoma.
Trial Design:
The study will be conducted using a prospective, double-blind randomized control trial in 2 institutions. Each arm will receive standard radiation to a total dose of 70 Gray (Gy) with concurrent chemotherapy. The primary objective is to compare the prevention of dermatitis and the primary endpoint is reached when grade 2 or higher dermatitis according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale occurs. Secondary objectives will be evaluation of the time to onset of dermatitis, the time to complete recovery from dermatitis and the degree of pain. Assessment of the patient's skin will be done at baseline, weekly during treatment, 1 week post treatment and unless the skin has resolved to baseline then every week up until 6 weeks post-treatment, which will mark the end of follow-up. The safety end-point is reached when grade 4 dermatitis occurs.
Hypothesis and statistics:
The investigators aim to demonstrate a 30% reduction in the incidence of grade 2 or higher dermatitis with StrataXRT. Using a 2-sided test at significance level 0.05 to detect the difference with a power of 80%, the investigators envisage a recruitment of 100-150 patients in total. The study duration is estimated to be 8 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard clinical practice (control) | No intervention | –aqueous cream normally prescribed by radiation oncologists |
| StrataXRT (intervention) | Active comparator | Device: StrataXRTsilicon-based gel for radiation dermatitis |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients who are 21 years of age or older
- histological diagnosis of head and neck carcinoma available
- patients who are to be treated with concurrent chemoradiation
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- no known allergy to StrataXRT or silicone
Key exclusion criteria (7 listed)
- patients who cannot apply the skin product or have it administered to them
- patients with comorbidities and/or on medications that may alter the response of the skin e.g. connective tissue disorder
- patients with existing rashes or wounds in the radiation field at baseline
- patients receiving concurrent cetuximab during radiotherapy
- previous radiotherapy to the head and neck region
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 |
|---|---|---|
| StrataXRTrandomized patient allocated to this group will receive StrataXRT for application during the treatment and 4 weeks further after the treatment ends. | Device | StrataXRT (intervention) |
Primary outcome
grade 2 acute radiation dermatitis
Time frame: 10 weeks
when patient develops grade 2 acute radiation dermatitis as scored by Common Terminology Criteria for Adverse Event (CTCAE) version 4.03 scale with grade 1 the mildest, Grade 1: faint erythema or dry desquamation Grade 2: moderate to brisk erythema; patchy moist desquamation; moderate edema Grade 3: moist desquamation other than skin folds and creases; bleeding induced by minor trauma or abrasion Grade 4: skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site Grade 5: death
1 secondary outcome
completion of scheduled post-treatment assessment at 6 weeks post-radiotherapy
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
David Chia principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StrataXRT in people with Head and Neck Cancers and Acute Radiation Dermatitis, run by National University Hospital, Singapore at 1 site in Singapore.
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 7 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Chia (67737888, david_chia@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grade 2 acute radiation dermatitis (time frame: 10 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 12 Dec 2024.