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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain
Standard care will include mouth wash with antibiotics.
Fujian Cancer Hospital Radiation Oncology Department
Fuzhou, Fujian, China
Change from Baseline Numeric Rating Scale for Pain(NRS scale) at 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.
Time frame: The NRS scale will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks
Incidence of Severe Acute Oral Mucositis (Grade of CTCAE ≥ 2)
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).
Time frame: The WHO score will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.
Change from Baseline Quality of Life at 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.)
Time frame: The EORTC QLQ-C30 shoule be completed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.
Change from Baseline Karnofsky Performance Status Scale at 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: The KPS Scale will be recoreded weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks
The Adverse events Related to lappaconitine
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.)
Time frame: The Adverse events Related to lappaconitinewill be recoreded weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.