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

NCT02729324 | Unknown Phase 2

• 1 other identifier: B2015-071-01
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Neoplasms; Radiodermatitis

Keywords

nasopharyngeal carcinoma (NPC); radiation dermatitis; intensity modulated radiation therapy (IMRT)

Outcome Measures

Primary Outcomes (4)

• Incidence of grade ≥ 3 radiation dermatitis

  Incidence of grade ≥ 3 radiation dermatitis according to CTCAE version 4.0

  Day 56 after completion or termination of radiotherapy

• The Skindex-16

  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)

  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

• EORTC QLQ-C30

  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

Secondary Outcomes (2)

• Interruption time during the schedule of radiotherapy

  Through radiotherapy completion or termination, an average of 7 weeks

• Time for healing of radiation dermatitis

  Through study completion, an average of 15 weeks

Study Arms (2)

FORRAD group

EXPERIMENTAL

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®)

Biafine group

ACTIVE COMPARATOR

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)

Interventions

Medical Radiation Protectants (FORRAD®) DRUG

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.

FORRAD group

Trolamine (Biafine) DRUG

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.

Biafine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yun-fei Xia: lead

Study Sites (1)

Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (10)

• Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

  PMID: 21296855 BACKGROUND

• Zhang LF, Li YH, Xie SH, Ling W, Chen SH, Liu Q, Huang QH, Cao SM. Incidence trend of nasopharyngeal carcinoma from 1987 to 2011 in Sihui County, Guangdong Province, South China: an age-period-cohort analysis. Chin J Cancer. 2015 May 14;34(8):350-7. doi: 10.1186/s40880-015-0018-6.

  PMID: 26058679 BACKGROUND

• Blanchard P, Lee A, Marguet S, Leclercq J, Ng WT, Ma J, Chan AT, Huang PY, Benhamou E, Zhu G, Chua DT, Chen Y, Mai HQ, Kwong DL, Cheah SL, Moon J, Tung Y, Chi KH, Fountzilas G, Zhang L, Hui EP, Lu TX, Bourhis J, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy and radiotherapy in nasopharyngeal carcinoma: an update of the MAC-NPC meta-analysis. Lancet Oncol. 2015 Jun;16(6):645-55. doi: 10.1016/S1470-2045(15)70126-9. Epub 2015 May 6.

  PMID: 25957714 BACKGROUND

• Mao YP, Yin WJ, Guo R, Zhang GS, Fang JL, Chi F, Qi ZY, Liu MZ, Ma J, Sun Y. Dosimetric benefit to organs at risk following margin reductions in nasopharyngeal carcinoma treated with intensity-modulated radiation therapy. Chin J Cancer. 2015 May 20;34(5):189-97. doi: 10.1186/s40880-015-0016-8.

  PMID: 26058563 BACKGROUND

• Zheng Y, Han F, Xiao W, Xiang Y, Lu L, Deng X, Cui N, Zhao C. Analysis of late toxicity in nasopharyngeal carcinoma patients treated with intensity modulated radiation therapy. Radiat Oncol. 2015 Jan 13;10:17. doi: 10.1186/s13014-014-0326-z.

  PMID: 25582731 BACKGROUND

• Chan RJ, Webster J, Chung B, Marquart L, Ahmed M, Garantziotis S. Prevention and treatment of acute radiation-induced skin reactions: a systematic review and meta-analysis of randomized controlled trials. BMC Cancer. 2014 Jan 31;14:53. doi: 10.1186/1471-2407-14-53.

  PMID: 24484999 BACKGROUND

• Elliott EA, Wright JR, Swann RS, Nguyen-Tan F, Takita C, Bucci MK, Garden AS, Kim H, Hug EB, Ryu J, Greenberg M, Saxton JP, Ang K, Berk L; Radiation Therapy Oncology Group Trial 99-13. Phase III Trial of an emulsion containing trolamine for the prevention of radiation dermatitis in patients with advanced squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Trial 99-13. J Clin Oncol. 2006 May 1;24(13):2092-7. doi: 10.1200/JCO.2005.04.9148.

  PMID: 16648511 BACKGROUND

• Rollmann DC, Novotny PJ, Petersen IA, Garces YI, Bauer HJ, Yan ES, Wahner-Roedler D, Vincent A, Sloan JA, Issa Laack NN. Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis. Int J Radiat Oncol Biol Phys. 2015 Jul 1;92(3):650-8. doi: 10.1016/j.ijrobp.2015.02.028. Epub 2015 Apr 28.

  PMID: 25936812 BACKGROUND

• Fisher J, Scott C, Stevens R, Marconi B, Champion L, Freedman GM, Asrari F, Pilepich MV, Gagnon JD, Wong G. Randomized phase III study comparing Best Supportive Care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1307-10. doi: 10.1016/s0360-3016(00)00782-3.

  PMID: 11121627 BACKGROUND

• Pommier P, Gomez F, Sunyach MP, D'Hombres A, Carrie C, Montbarbon X. Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. J Clin Oncol. 2004 Apr 15;22(8):1447-53. doi: 10.1200/JCO.2004.07.063.

  PMID: 15084618 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Radiodermatitis; Nasopharyngeal Carcinoma

Interventions

triethanolamine; Biafine

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Yun-fei Xia, M.D.

CONTACT

+86-20-87343096; xiayf@sysucc.org.cn

Wenwen Zhang, M.D.

CONTACT

+86-20-87343096; zhangww@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Department of Radiation Oncology

Study Record Dates

• First Submitted: March 27, 2016
• First Posted: April 6, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 6, 2016

Record last verified: 2016-03

Locations

CN (1)