Clinical trial NCT02729324: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Neoplasms
Radiodermatitis
Keywords: nasopharyngeal carcinoma (NPC)
radiation dermatitis
intensity modulated radiation therapy (IMRT)
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Pathologically confirmed and previously untreated nasopharyngeal carcinoma.
2. Age ≥ 18 years and ≤ 65 years.
3. Karnofsky performance status (KPS) score ≥ 70.
4. No prior radiation or surgery in the head and neck.
5. No contraindication to radiotherapy.
6. Planned to receive radiotherapy alone or concurrent chemoradiotherapy, with intensity-modulated radiation therapy (IMRT).
7. Adequate bone marrow function: while blood cell \>= 3,000/μL, absolute neutrophil count \>= 1,500/μL, hemoglobin \>= 100g/L, platelet \>= 75,000/μL.
8. Life expectancy of \>= 3 months.

Exclusion Criteria:

1. Known allergic reaction to any component of Medical Radiation Protectants (FORRAD®) or Trolamine (Biafine), or severe allergic constitution.
2. Other conditions that the investigators consider as inappropriate for enrolling into this study.

Primary outcomes:
measure: Incidence of grade ≥ 3 radiation dermatitis
timeFrame: Day 56 after completion or termination of radiotherapy
measure: The Skindex-16
timeFrame: Day 56 after completion or termination of radiotherapy
measure: The symptom experience diary (SED)
timeFrame: Day 56 after completion or termination of radiotherapy
measure: EORTC QLQ-C30
timeFrame: Day 56 after completion or termination of radiotherapy
Secondary outcomes:
measure: Interruption time during the schedule of radiotherapy
timeFrame: Through radiotherapy completion or termination, an average of 7 weeks
measure: Time for healing of radiation dermatitis
timeFrame: Through study completion, an average of 15 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
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