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Appaconitine Patch for Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT03518489
Recruitment Status : Not yet recruiting
First Posted : May 8, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Fujian Cancer Hospital

Brief Summary:
The purpose of this clinical study is to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain and the improvements in QOL of patients with nasopharyngeal carcinoma . To determine if lappaconitine administered prior to radiation therapy reduces the severity of radiation induced oral mucositis pain in patients who have been diagnosed with nasopharyngeal carcinoma.

Condition or disease Intervention/treatment Phase
Radiation Induced Oral Mucositis Drug: Lappaconitine Adhesive Patch Drug: standard care Not Applicable

Detailed Description:

This is a randomized, single -center study conducted in China to evaluate Lappaconitine Adhesive Patch in the reduction severity of radiation induced oral mucositis pain in patients receiving solo radiation therapy or chemoradiation therapy for nasopharyngeal carcinoma.

Patients will reveive daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for 3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).

Patients in both arms received Intensity Modulated Radiation Therapy(IMRT) :All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 50 and 62. The prescribed dose is 68-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-68 Gy to GTVnd (Gross tumor volume of the cervical lymph node), 60- 64Gy to PTVnd and PTV1 (Planning target volume 1), and 54-58 Gy to PTV2 (Planning target volume 2) in 30-32 fractions.

Patients will be randomized equally to 1 of 2 treatment arms:

Arm A: Lappaconitine Adhesive Patch per day, concurrent with stardard care for oral mucositis Arm B: stardard care for oral mucositis

All patients will be assessed weekly for oral mucositis per WHO grading criteria until the completion of IMRT, and once weekly thereafter (if necessary) for 7 weeks, or until oral mucositis resolves to ≤ Grade 1.

Approximately 200 patients will be enrolled to ensure that roughly 80 patients per arm complete treatments for primary endpoint analysis.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Lappaconitine Adhesive Patch for the Treatment of Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer : A Randomized, Prospective Single-center Controlled Study
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Lappaconitine Adhesive Patch Lappaconitine Adhesive Patch is administered every radiation day, until the end of radiotherapy.
Drug: Lappaconitine Adhesive Patch
to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain
Other Name: standard care

Active Comparator: Control
Patients will be given standard care when oral pain is reported
Drug: standard care
Standard care will include mouth wash with antibiotics.




Primary Outcome Measures :
  1. Change from Baseline Numeric Rating Scale for Pain(NRS scale) at 7 weeks [ Time Frame: The NRS scale will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks ]
    The pain caused by oral mucositis for all participants was assessed according to Numeric Rating Scale (NRS scale), by which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. And an 11-point scale where 0 indicates no pain and 10 indicates the worst imaginable pain. The scale for each patient was recorded.


Secondary Outcome Measures :
  1. Incidence of Severe Acute Oral Mucositis (Grade of CTCAE ≥ 2) [ Time Frame: The WHO score will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks. ]
    The Oral Mucositis Score of World Health Organization (WHO) was classified based on the changes of patients' oral mucosa and ability to eat, and are classified to 4 grades. WHO scale for oral mucositis (available in: Peterson DE, Boersdoets CB, Bensadoun RJ, et al. Management of oral and gastrointestinal mucosal injury: ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up. Annals of Oncology 2015; 26(supply5). https://doi.org/10.1093/annonc/mdv202 ): Grade 0 = no oral mucositis; Grade 1 = erythema and soreness; Grade 2 = ulcers, able to eat solids; Grade 3 = ulcers, requires liquid diet (due to mucositis); Grade 4 = ulcers, alimentation not possible (due to mucositis).

  2. Change from Baseline Quality of Life at 7 weeks [ Time Frame: The EORTC QLQ-C30 shoule be completed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks. ]
    he quality of life for all participants was evaluated according to The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (available in: Grønvold M. EORTC QLQ-C30 Scoring Manual 2014.)

  3. Change from Baseline Karnofsky Performance Status Scale at 7 weeks [ Time Frame: The KPS Scale will be recoreded weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks ]
    The functional status for all participants was assessed according to Karnofsky Performance Status Scale (KPS Scale) (available in: Friendlander AH, Ettinger RL. Karnofsky performance status scale[J]. Special Care in Dentistry, 2009, 29(4):147.). The KPS Scale was range from 0 to 100, and were averagely divided into eleven grades begin with 0.

  4. The Adverse events Related to lappaconitine [ Time Frame: The Adverse events Related to lappaconitinewill be recoreded weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks. ]
    The adverse events related to lappaconitine based on medicine specification of lappaconitine was observed and recorded down according to Common toxicity criteria, version 2.0. (available in: Version CTC, Version CTC, Date P, et al. Common toxicity criteria (ctc) 1999.)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly histologic diagnosis of nasopharyngeal carcinoma without distant metastasis
  • Clinical stage III~IVa( UICC (Union International Against Cancer) /AJCC (American Joint Committee on Cancer) TNM staging system 8th edition)
  • Karnofsky Performance Status Scale between 60-100
  • WBC count ≥ 4×109/L,neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L
  • ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
  • Sign the informed consent.

Exclusion Criteria:

  • Younger than 18 years old or older than 70 years old
  • Pregnancy or lactation
  • Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
  • Have suffered from other tumor or now suffering from other tumor
  • Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases
  • Refuse to give up smoking/drinking/betel chewing
  • suffering from other active infection diseases and in need of treatment.

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): NCT03518489


Contacts
Contact: Jing Huang, master 13375001112 huangjing2567@163.com

Locations
China, Fujian
Fujian Cancer Hospital Radiation Oncology Department Recruiting
Fuzhou, Fujian, China, 350014
Contact: wu zhuang, master    0086-02083660063    fjthkjk@sohu.com   
Sponsors and Collaborators
Fujian Cancer Hospital
Investigators
Study Director: Shufang Qiu, M.D. Fujian Cancer Hospital

Responsible Party: Fujian Cancer Hospital
ClinicalTrials.gov Identifier: NCT03518489     History of Changes
Other Study ID Numbers: FujianCH
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Mucositis
Stomatitis
Nasopharyngeal Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Lappaconitine
Aconitine
Anti-Arrhythmia Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Voltage-Gated Sodium Channel Agonists
Sodium Channel Agonists
Membrane Transport Modulators