Clinical Trial: 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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Comparison of Efficacy and Safety Between Medical Radiation Protectants (FORRAD®) and Trolamine (Biafine) for the Management of Radiation Dermatitis in Patients With

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 Summary:

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.
Sponsor: Yun-fei Xia

Current Primary Outcome:

  • Incidence of grade ≥ 3 radiation dermatitis [ Time Frame: Day 56 after completion or termination of radiotherapy ]
    Incidence of grade ≥ 3 radiation dermatitis according to CTCAE version 4.0
  • The Skindex-16 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Interruption time during the schedule of radiotherapy [ Time Frame: Through radiotherapy completion or termination, an average of 7 weeks ]
    The cumulative interruption time during the schedule of radiotherapy because of grade 3 or higher radiation dermatitis.
  • Time for healing of radiation dermatitis [ Time Frame: Through study completion, an average of 15 weeks ]
    Time until healing of radiation dermatitis, after the completion or the termination of radiotherapy.


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: March 27, 2016
Date Started: April 2016
Date Completion: June 2017
Last Updated: April 5, 2016
Last Verified: March 2016