Trials / Unknown

UnknownNCT02729324

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

Status: Unknown
Phase: Phase 2
Study type: Interventional
Enrollment: 136 (estimated)

Sponsor: Yun-fei Xia · Academic / Other
Sex: All
Age: 18 Years – 65 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
DRUG	Medical Radiation Protectants (FORRAD®)	Medical Radiation Protectants (FORRAD®) is prescribed at the beginning of radiotherapy for free. Patients are asked to start topical application of Medical Radiation Protectants (FORRAD®) on irradiated skin at the onset of radiotherapy, three times a day (30 minutes before radiotherapy, after radiotherapy, and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation dermatitis. When grade 2 or higher radiation dermatitis is developed, patients can continue using Medical Radiation Protectants (FORRAD®). When grade 3 or higher radiation dermatitis happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted, until moist desquamation is cured.
DRUG	Trolamine (Biafine)	Trolamine (Biafine) is prescribed at the beginning of radiotherapy. Patients are asked to start topical application of trolamine (Biafine) on irradiated skin at the onset of radiotherapy, three times a day, until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation dermatitis. No other prophylactic creams, lotions, or gels are allowed. When grade 2 or higher radiation dermatitis is developed, patients cannot use trolamine any more, and they will receive other conventional medical care for treatment of radiation dermatitis in the investigators institution. When grade 3 or higher radiation dermatitis happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted, until moist desquamation is cured.

Timeline

Start date: 2016-04-01
Primary completion: 2017-06-01
Completion: 2017-06-01
First posted: 2016-04-06
Last updated: 2016-04-06

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02729324. Inclusion in this directory is not an endorsement.