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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство StrataXRT
  randomized patient allocated to this group will receive StrataXRT for application during the treatment and 4 weeks further after the treatment ends.

Первичные конечные точки

• grade 2 acute radiation dermatitis [Срок оценки: 10 weeks]

Вторичные конечные точки (1)

• completion of scheduled post-treatment assessment at 6 weeks post-radiotherapy [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Сингапур · 1 центр

• National University Hospital — Singapore

Идентификаторы

NCT: NCT03394417 · 2016/01084

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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