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

April 5, 2016 updated by: Yun-fei Xia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FORRAD group
This group of patients will receive Medical Radiation Protectants (FORRAD®) during study for prevention and treatment of acute radiation-induced dermatitis. This is the experimental group.
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.
ACTIVE_COMPARATOR: Biafine group
This group of patients will receive Trolamine (Biafine) during study for prevention and treatment of acute radiation-induced dermatitis. This is the active comparator group.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 56 after completion or termination of radiotherapy
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
Day 56 after completion or termination of radiotherapy
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.
Day 56 after completion or termination of radiotherapy
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).
Day 56 after completion or termination of radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through radiotherapy completion or termination, an average of 7 weeks
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.
Through study completion, an average of 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yun-fei Xia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

March 27, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (ESTIMATE)

April 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2015-071-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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