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Trial record 2 of 6 for:    "Nasopharyngeal Carcinoma" | "Dexamethasone acetate"

Efficacy and Safety of FORRAD® for the Management of Radiation-induced Mucositis in Patients With Nasopharyngeal Carcinoma Receiving IMRT

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ClinicalTrials.gov Identifier: NCT02735317
Recruitment Status : Unknown
Verified April 2016 by Yun-fei Xia, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : April 12, 2016
Last Update Posted : April 12, 2016
Sponsor:
Information provided by (Responsible Party):
Yun-fei Xia, Sun Yat-sen University

Brief Summary:
Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The most frequently occurred radiation-related side effect is probably the radiation-induced oral mucositis (OM), which affects up to 100% of NPC patients receiving radiation therapy. When severe, oral mucositis increases the risk of infection and may compromise clinical outcomes by necessitating treatment breaks, dosage reductions, and reduced therapy compliance. In China, a quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine, is commonly prescribed when NPC patients begin to suffer from radiation-induced OM. However, the incidence of radiation-induced OM is still quite high. Oral Ulcer Gargle (FORRAD®) is a proprietary viscous liquid mucoadhesive hydrogel formulation. It creates a palliative barrier over injured mucosa, to prevent and to cure radiation-induced OM. The objective of this randomized phase II study is to assess the efficacy and safety of Oral Ulcer Gargle (FORRAD®) as an intervention for radiation-induced OM in the treatment of NPC, compared with the commonly used quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin B12, and procaine.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Neoplasms Stomatitis Drug: Oral Ulcer Gargle (FORRAD®) Drug: Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine Phase 2

Detailed Description:

Nasopharyngeal carcinoma (NPC) is one of the most common malignances in South China. Radiation therapy remains the principal treatment for NPC. The most frequently occurred radiation-related side effect is probably the radiation-induced oral mucositis (OM), which affects up to 100% of NPC patients receiving radiation therapy. Although intensity modulated radiation therapy (IMRT) has been widely used in China nowadays, the incidence of radiation-induced oral mucositis is still high. OM can decrease patients' oral intake and nutrition, leading to dehydration, weight loss, and declining performance status that may require intravenous fluid hydration, feeding tube placement, and hospitalization. OM also may increase opioid use. When severe, oral mucositis increases the risk of infection and may compromise clinical outcomes by necessitating treatment breaks, dosage reductions, and reduced therapy compliance. Common clinical management strategies include bland rinses, topical anesthetics and analgesics, mucosal coating agents, and systemic analgesics. However, none of these interventions has been supported by conclusive evidence. In China, a quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine, is commonly prescribed when NPC patients begin to suffer from radiation-induced OM.

Oral Ulcer Gargle (FORRAD®) is a proprietary viscous liquid mucoadhesive hydrogel formulation. It creates a palliative barrier over injured mucosa, to prevent and to cure radiation-induced OM.

The objective of this randomized phase II study is to assess the efficacy and safety of Oral Ulcer Gargle (FORRAD®) as an intervention for radiation-induced OM in the treatment of NPC, compared with the commonly used quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin B12, and procaine.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of FORRAD® for the Management of Radiation-induced Mucositis in Patients With Nasopharyngeal Carcinoma Receiving IMRT: A Single-center, Randomized Controlled Trial
Study Start Date : April 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FORRAD group

This group of patients will receive Oral Ulcer Gargle (FORRAD®) during study for prevention and treatment of acute radiation-induced oral mucositis (OM).

This is the experimental group.

Drug: Oral Ulcer Gargle (FORRAD®)
Oral Ulcer Gargle (FORRAD®) is prescribed at the beginning of radiotherapy for free. Patients are asked to start application of Oral Ulcer Gargle (FORRAD®) at the onset of radiotherapy, four times a day (after meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade > 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted.

Active Comparator: Quadruple mixture group

This group of patients will receive quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin B12, and procaine, during study for prevention and treatment of acute radiation-induced oral mucositis (OM).

This is the active comparator group.

Drug: Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine
Quadruple mixture is prescribed at the beginning of radiotherapy. Patients are asked to start application of quadruple mixture at the onset of radiotherapy, four times a day (before meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade > 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted.




Primary Outcome Measures :
  1. Incidence of grade ≥ 3 mucositis [ Time Frame: Day 56 after completion or termination of radiotherapy ]
    Incidence of grade ≥ 3 mucositis according to CTCAE version 4.0

  2. OMAS [ Time Frame: Day 56 after completion or termination of radiotherapy ]
    Oral Mucositis Assessment Scale (OMAS) provides an objective assessment of oral mucositis based on assessment of the appearance and extent of redness and ulceration in various areas of the mouth.

  3. OMDQ MTS question 2 (Q2) score [ Time Frame: Day 56 after completion or termination of radiotherapy ]
    Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness (MTS) question 2 (Q2) is a 5-point categorical scale in which patients grade MTS from 0 (no soreness) to 4 (extreme soreness)3 which is a component of the OMDQ in that it tracks very well with objective (WHO score and opioid use) and subjective measurement of OM severity.

  4. WHO score [ Time Frame: Day 56 after completion or termination of radiotherapy ]
    The World Health Organization (WHO) Oral Toxicity score combines both elements into a single score that grades the severity of the condition from 0 (no oral mucositis) to 4 (swallowing not possible such that patient needs supplementary nutrition).

  5. 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.


Secondary Outcome Measures :
  1. 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 4 or higher radiation-induced oral mucositis.

  2. Time for healing of radiation-induced oral mucositis [ Time Frame: Through study completion, an average of 15 weeks ]
    Time until healing of radiation-induced oral mucositis, after the completion or the termination of radiotherapy.

  3. The cumulative dose of opioid used [ Time Frame: Through study completion, an average of 15 weeks ]
    The cumulative dose of opioid used from the beginning of radiotherapy until the completion of study.

  4. The cumulative time using opioid [ Time Frame: Through study completion, an average of 15 weeks ]
    The cumulative time using opioid from the beginning of radiotherapy until the completion of study.

  5. The change of body weight from baseline. [ Time Frame: Baseline and 7 weeks ]
    The change of body weight before radiotherapy and the day when radiotherapy is completed or terminated.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Planned to receive radiotherapy alone or concurrent chemoradiotherapy, with intensity-modulated radiation therapy (IMRT).
  5. Adequate bone marrow function: while blood cell >= 3,000/μL, absolute neutrophil count >= 1,500/μL, hemoglobin >= 100g/L, platelet >= 75,000/μL.
  6. Life expectancy of >= 3 months.

Exclusion Criteria:

  1. Known allergic reaction to any component of Oral Ulcer Gargle (FORRAD®) or quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin B12, and procaine, or severe allergic constitution.
  2. Other conditions that the investigators consider as inappropriate for enrolling into this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735317


Contacts
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Contact: Yun-fei Xia, M.D. +86-20-87343096 xiayf@sysucc.org.cn
Contact: Wenwen Zhang, M.D. +86-20-87343096 zhangww@sysucc.org.cn

Locations
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China, Guangdong
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Yun-fei Xia

Publications:

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Responsible Party: Yun-fei Xia, Director of the Department of Radiation Oncology, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02735317     History of Changes
Other Study ID Numbers: B2015-074-01
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016
Keywords provided by Yun-fei Xia, Sun Yat-sen University:
Nasopharyngeal carcinoma (NPC)
radiotherapy
oral mucositis (OM)
Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Dexamethasone
Carcinoma
Nasopharyngeal Neoplasms
Mucositis
Stomatitis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Gentamicins
Procaine
Micronutrients
Nutrients
Growth Substances