StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients

Head and Neck Cancers Clinical Trial

Official title:

StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Patients Receiving Concurrent Chemoradiation for Head and Neck Cancers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03394417
• Other study ID #: 2016/01084
• Status: Not yet recruiting
• Phase: N/A
• First received: January 3, 2018
• Last updated: January 7, 2018
• Start date: February 2018
• Est. completion date: August 2020

Study information

• Verified date: December 2017
• Source: National University Hospital, Singapore
• Contact: David Chia
• Phone: 67795555
• Email: david_chia[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 2 years.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Radiation Dermatitis
• Dermatitis
• Head and Neck Cancers
• Head and Neck Neoplasms
• Radiodermatitis

Intervention

Device:
• StrataXRT
randomized patient allocated to this group will receive 2 50g tubes of StrataXRT for application during the treatment and 4 weeks further after the treatment ends.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 weeks
Secondary	completion of scheduled post-treatment assessment at 6 weeks post-radiotherapy	when patient completed the scheduled post-radiotherapy assessment	12 weeks