Symptoms and General Pathology

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Neoplasms by Histologic Type

Anti-Infective Agents

All Drugs and Chemicals

Anti-Arrhythmia Agents

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Psychotropic Drugs

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Antibiotics, Antitubercular

Lappaconitine

Analgesics, Non-Narcotic

Lappaconitine Adhesive Patch Lappaconitine Adhesive Patch is administered every radiation day, until the end of radiotherapy.

Patients will be given standard care when oral pain is reported

to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain

Lappaconitine Adhesive Patch

Standard care will include mouth wash with antibiotics.

standard care

Jing Huang, master

wu zhuang, master

Shufang Qiu, M.D.

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.

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

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

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.

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).

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.)

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.

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.)

Fujian Cancer Hospital

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Herbal and Botanical

Turmeric extract

Curcumin

Mitogens

Anti-Inflammatory Agents, Non-Steroidal

Enzyme Inhibitors

Turmeric

Curcuma longa oral gel for prevention radiation induced oral mucositis

Curcumin Gel

Standard preparation for prevention radiation induced oral mucositis

Standard Preparation

The goal of this clinical study is to investigate the effect of a curcuma longa oral gel (curenext) on reducing radiation-induced oral mucositis severity in cancer patients and provide a context for understanding if there is a relationship between the curcumin clinical effect and production of EGFs and IL8.

Researchers will compare between curcumin group and standard treatment group.

Two groups A) curcuma longa oral gel group B) standard treatment group

Curcumin Gel On Radiation Induced Oral Mucositis

The Effect of Curcuma Long Oral Gel in Relation to Salivary Epidermal Growth Factor & Interleukin-8 on Radiation Induced Oral Mucositis in Iraqi Cancer Patients

Onset (at which week) of radiation induced mucositis in relation to EGF and IL8

Change in severity (degree of illness) of radiation induced mucositis in relation to EGF \& IL-8 by World Health Organization (WHO) mucositis scale {0: no. 1: mild. 2 and 3 : moderate. 4: severe}

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Appaconitine Patch for Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer	NCT03518489	Radiation Induc...	Lappaconitine A... standard care	18 Years - 70 Years	Fujian Cancer Hospital
Appaconitine Patch for Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer	NCT03518489	Radiation Induc...	Lappaconitine A... standard care	18 Years - 70 Years	Fujian Cancer Hospital
Curcumin Gel On Radiation Induced Oral Mucositis	NCT05982197	Radiation-Induc... Head and Neck C...	Curcumin Gel Standard Prepar...	16 Years - 80 Years	University of Baghdad
Appaconitine Patch for Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer	NCT03518489	Radiation Induc...	Lappaconitine A... standard care	18 Years - 70 Years	Fujian Cancer Hospital

Spots Global Cancer Trial Database for radiation induced oral mucositis