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The effect of Dendrobium ferruginum in the treatment of radiation oral mucositis in nasopharyngeal carcinoma and its improvement of oral microecology

Registration number：

ITMCTR2024000483

Date of Last Refreshed on：

2024-09-26

Date of Registration：

2024-09-26

Registration Status：

Retrospective registration

Public title：

The effect of Dendrobium ferruginum in the treatment of radiation oral mucositis in nasopharyngeal carcinoma and its improvement of oral microecology

English Acronym：

Scientific title：

The effect of Dendrobium ferruginum in the treatment of radiation oral mucositis in nasopharyngeal carcinoma and its improvement of oral microecology

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Jiaying Yang

Study leader：

Aiqin Zhang

Applicant telephone：

+86 198 5716 7207

Study leader's telephone：

+86 137 7746 2976

Applicant Fax：

Study leader's fax：

Applicant E-mail：

littleyjy921@163.com

Study leader's E-mail：

zhanghaojianbb@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Zhejiang University of Chinese Medicine 548 Binwen Road Binjiang District Hangzhou City Zhejiang ProvinceChina

Study leader's address：

Department of Traditional Chinese Medicine Zhejiang Cancer Hospital No.1 Banshan East Road Gongshu District Hangzhou City Zhejiang Province China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The Second Clinical School of Zhejiang University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

IRB-2022-709号(科)

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Zhejiang Cancer Hospital

Date of approved by ethic committee：

2022/11/29 0:00:00

Contact Name of the ethic committee：

Lihong Wang

Contact Address of the ethic committee：

Zhejiang Cancer Hospital No.1 Banshan East Road Gongshu District Hangzhou City Zhejiang Province China

Contact phone of the ethic committee：

+86 135 7572 5157

Contact email of the ethic committee：

ec@zjcc.org.cn

Primary sponsor：

Zhejiang Cancer Hospital

Primary sponsor's address：

Zhejiang Cancer Hospital No.1 Banshan East Road Gongshu District Hangzhou City Zhejiang Province China

Secondary sponsor：

Country：

China

Province：

Zhejiang

City：

Hangzhou

Institution
hospital：

Zhejiang Cancer Hospital

Address：

Zhejiang Cancer Hospital No.1 Banshan East Road Gongshu District Hangzhou City Zhejiang Province China

Source(s) of funding：

Zhejiang Province basic public welfare program project

Target disease：

Nasopharyngeal carcinoma

Target disease code：

Study type：

Interventional study

Study design：

Non randomized control

Study phase：

Pilot clinical trial

Objectives of Study：

In this study Dendrobium officinale was used as a substitute tea drink. Dendrobium officinale substitute tea was taken internally after radiotherapy or symptoms related to radioactive oral mucositis. The grade of oral mucositis and salivary gland function were evaluated after treatment. The immune function and oral flora were tested to further explain the scientific connotation of Dendrobium officinale in the treatment of radioactive oral mucositis. The completion of this study is helpful to clarify the effect of Dendrobium officinale on radiation oral mucositis and reveal the mechanism of Dendrobium officinale improving oral microecology. It has important theoretical significance and practical value to promote the application of Dendrobium officinale in patients with radioactive oral mucositis.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Age 30 to 50 years old; ② Confirmed diagnosis of nasopharyngeal carcinoma by pathology; (3) Patients who meet the diagnostic criteria of radiation oral mucositis in Western medicine; (4) Patients without obvious oral pharyngitis symptoms and oral mucosal injury before radiotherapy; ⑤ Sign informed consent and agree to join the cohort.

Exclusion criteria：

① Serious diseases combined with non-malignant tumors will affect the patient's compliance or put the patient in a dangerous state; ② Accompanying other anti-tumor therapies or participating in other clinical trials; Patients using antibiotics: included those who had received systemic high dose of antibiotics within 3 months before enrollment those who had long-term systemic use of antibiotics or those who had long-term use of antibacterial mouthwash. ④ Patients who use other drugs for oral mucositis at the same time; ⑤ Patients with Behcet's disease systemic lupus erythematosus diabetes and other diseases.

Study execute time：

From 2022-11-29

To      2023-10-31

Recruiting time：

From 2022-11-30

To      2023-10-31

Interventions：

54

Group：

Experimental group

Sample size：

Intervention：

Compound vitamin B12 solution + Dendrobium officinale tea drink. Dendrobium officinale 12g (provided by Zhejiang Cancer Hospital Pharmacy), decocted to 600ml by pharmacy machine, divided into equal parts according to proportion and taken internally in the form of tea. Treatment for 1 month is a course of treatment.

Intervention code：

54

Group：

Control group

Sample size：

Intervention：

Gargle with compound vitamin B12 solution 3 times/day. Do not gargle within 30 minutes after medication. Fast and water should be prohibited. Treatment for 1 month is a course of treatment.

Intervention code：

Total sample size ： 108

Countries of recruitment
and research settings：

Country：

China

Province：

Zhejiang

City：

Hangzhou

Institution/hospital：

Zhejiang Cancer Hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

TCM syndrome score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Acute radiation oral mucositis scale

Type：

Secondary indicator

Measure time point of outcome：

At the onset of radioactive oral mucosal inflammation (at 10F radiotherapy) and 1 month after Dendrobium treatment (at the end of radiotherapy)

Measure method：

Ask and evaluate symptoms

Outcome：

Immune-related factor

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Immune-related factor IL-10

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Immune factor

Type：

Primary indicator

Measure time point of outcome：

Radiation oral mucositis at 10F of radiotherapy and 1 month after Dendrobium treatment at the end of radiotherapy

Measure method：

Outcome：

Oral flora

Type：

Primary indicator

Measure time point of outcome：

Radiation oral mucositis at 10F of radiotherapy and 1 month after Dendrobium treatment at the end of radiotherapy

Measure method：

Outcome：

Salivary flow rate

Type：

Secondary indicator

Measure time point of outcome：

Radiation oral mucositis at 10F of radiotherapy and 1 month after Dendrobium treatment at the end of radiotherapy

Measure method：

Cotton swab method

Outcome：

Immune-related factor IL-11

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

saliva

Tissue：

Fate of sample 

Destruction after use

Note：

Completed

18
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Patients were assigned a number according to the order of enrollment random seed number was set and random number was generated by R3.6.1 software corresponding to the patient number. According to the size of random number the first 50% would enter the control group and the last 50% would enter the experimental group.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

NONE

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

NONE

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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