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Comparison of Efficacy and Safety Between Medical Radiation Protectants (FORRAD®) and Trolamine (Biafine) for the Management of Radiation Dermatitis in Patients With Nasopharyngeal Carcinoma Receiving IMRT: A Single-center, Randomized Controlled Trial
Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). Although intensity modulated radiation therapy (IMRT) has been widely used in China nowadays, radiation dermatitis is still common. It has an impact on pain and quality of life, and if severe, may lead to interruption of the radiation schedule for the patient. Trolamine (Biafine; Genmedix Ltd, France) is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. However, as long as grade ≥2 radiation dermatitis is developed, trolamine is not allowed to use any more. Medical Radiation Protectants (FORRAD®) is a new kind of topical agents for prevention and treatment of radiation dermatitis. It could be used during the course of radiotherapy, even when grade ≥2 dermatitis is developed. This randomized phase II study is aimed to assess the effectiveness and safety of Medical Radiation Protectants (FORRAD®) for the prevention and treatment of acute radiation-induced dermatitis of grade 3 or higher during IMRT for patients with NPC, compared with trolamine.
Details
| Lead sponsor | Yun-fei Xia |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 136 |
| Start date | 2016-04 |
| Completion | 2017-06 |
Conditions
- Nasopharyngeal Neoplasms
- Radiodermatitis
Interventions
- Medical Radiation Protectants (FORRAD®)
- Trolamine (Biafine)
Primary outcomes
- Incidence of grade ≥ 3 radiation dermatitis — Day 56 after completion or termination of radiotherapy
Incidence of grade ≥ 3 radiation dermatitis according to CTCAE version 4.0 - The Skindex-16 — Day 56 after completion or termination of radiotherapy
The skindex-16 is an analogue scale of symptoms and functional endpoints related to skin toxicity that may occur in the radiation treatment area. The mean AUC of Skindex-16 score over time. Patients were asked to complete the Skindex-16 only in reference to the skin receiving RT. - The symptom experience diary (SED) — Day 56 after completion or termination of radiotherapy
The symptom experience diary (SED) required the patient to rate the severity of multiple skin toxicity-related signs and symptoms on a scale of 0 (do not experience) to 10 (experience all the time). - EORTC QLQ-C30 — Day 56 after completion or termination of radiotherapy
EORTC QLQ-C30 is a Quality-of-Life Instrument proposed by the European Organization for Research and Treatment of Cancer (EORTC), for use in International Clinical Trials in Oncology. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale.
Countries
China