Nasopharyngeal Neoplasms Clinical Trial
Official title:
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.
Nasopharyngeal carcinoma (NPC) is one of the most common malignances in South China.
Radiation therapy remains the principal treatment for NPC. One of the frequently occurred
radiation-related side effects includes radiation-induced skin reactions (RISR), also known
as radiation dermatitis, which affects up to 90% of cancer patients receiving radiation
therapy. Although intensity modulated radiation therapy (IMRT) has been widely used in China
nowadays, radiation dermatitis is still common. It is often characterized by edema,
erythema, changes in pigmentation, fibrosis, and ulceration, and may cause signs and
symptoms, such as skin dryness, itching discomfort, pain, warmth, and burning. Radiation
dermatitis has an impact on pain and quality of life in this patient group, and if severe,
may lead to interruption of the radiation schedule for the patient.
A variety of interventions are used for prophylaxis and management of radiation dermatitis.
However, a recent overview of systematic review and meta-analysis of randomized controlled
trials concluded that the use of these interventions is not yet supported by conclusive
evidence and therefore warrants further investigations.
Trolamine (Biafine; Genmedix Ltd, France) is an oil-in-water emulsion that can enhance skin
healing by recruiting macrophages and modifying the concentrations of various
immunomodulators. In China, Trolamine is commonly prescribed at the beginning of
radiotherapy for preventing acute radiation-induced skin toxicity. 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.
The primary aim of this randomized phase II study is 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT00577057 -
Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer
|
N/A | |
| Completed |
NCT01256853 -
Modified Vaccinia Ankara (MVA) Vaccine Study
|
Phase 1 | |
| Recruiting |
NCT02945878 -
Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma
|
N/A | |
| Terminated |
NCT02874651 -
ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy
|
Phase 2 | |
| Not yet recruiting |
NCT05807880 -
Anlotinib, Penpulimab and Capecitabine in Recurrent/Metastatic Nasopharyngeal Carcinoma
|
Phase 2 | |
| Completed |
NCT00342147 -
Family Study of Head and Neck Cancers in Taiwan
|
||
| Recruiting |
NCT02980315 -
A New EBV Related Technologies of T Cells in Treating Malignant Tumors and Clinical Application
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01735409 -
Dose-finding Study of Abraxane in Combination With Cisplatin to Treat Advanced Nasopharyngeal Carcinoma
|
Phase 1/Phase 2 | |
| Completed |
NCT00565448 -
Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
|
Phase 2 | |
| Completed |
NCT00630149 -
Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Have Had Prior Platinum Based Chemotherapy
|
Phase 2 | |
| Active, not recruiting |
NCT03854838 -
IMRT Combined With Toripalimab in Unresectable Locally Recurrent Nasopharyngeal Carcinoma.
|
Phase 2 | |
| Completed |
NCT01797900 -
The Role of Induction Chemotherapy for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT
|
Phase 2 | |
| Completed |
NCT00436800 -
Gemcitabine and Oxaliplatin (GEMOX) in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT00563927 -
Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0)
|
N/A | |
| Not yet recruiting |
NCT04870905 -
Tisleilizumab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT02902432 -
A Trial of Endostar in Patients With Carcinoma of the Head and Neck
|
Phase 2 | |
| Active, not recruiting |
NCT02456506 -
Hyperfractionated Intensity-modulated Radiotherapy (IMRT) Versus Conventional Fraction IMRT for Patients With Loco-regionally Recurrent Nasopharyngeal Carcinoma.
|
N/A | |
| Completed |
NCT02444949 -
A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma
|
Phase 2 | |
| Completed |
NCT00188877 -
Intensity Modulated Radiation Therapy for Head and Neck Cancer
|
Phase 2 | |
| Terminated |
NCT00393224 -
Defining the Clinical Utility of EBV Antibody Screening to Identify Individuals Susceptible to Nasopharyngeal Carcinoma (NPC) Within High-Risk, Multiplex NPC Families
|