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Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ChiNing decoction
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Cancer focused on measuring head and neck cancer, chemoradiotherapy, radioactive stomatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Head and neck cancer patients with pathology and / or cytologic diagnosis;
  • Age 18~75 years old;
  • The expected life is more than 3 months;
  • The Karnofsky score (Karnofsky) ≥70 points;
  • The first course of radiotherapy in patients;
  • Patients had not received any anti tumour therapies for example of operation, radiotherapy,chemotherapy, biological treatment or isotope therapy system;
  • Patients volunteered to participate in this test and signed the informed consent, understand the purpose and test steps of the test, good compliance, comply with the relevant requirements of this test scheme;
  • No history of oral ulcer and salivary gland diseases

Exclusion Criteria:

  • That do not meet the above the inclusion criteria;
  • Advanced critical cases, the expected survival is less than 3 months;
  • The patients had serious complications, such as cachexia, hepatic encephalopathy, gastrointestinal bleeding and coagulation functionobstruction, su ch as abnormal;
  • The submandibular gland pathological changes;
  • During radiotherapy taking other drugs in patients with treatment of stomatitis;
  • The patients with serious heart, brain, liver, kidney function

Sites / Locations

  • Tianjin Medical University Cancer Institute and Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ChiNing decoction

rhEGF spray

Arm Description

60ml ChiNing decoction by mouth，three times a day for 46 days.

The rhEGF spray spray on the oral mucosal surface irradiated area, 3 times a day for 46 days.

Outcomes

Primary Outcome Measures

Grading standard of RTOG in acute radiation injury of oral mucosal
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy

Secondary Outcome Measures

The visual analogue scale of oral pain
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
EORTCQLQ-H&N35
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
patient body weight changes
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Safety index
Chech the blood routine, urine routine, liver and kidney function, electrocardiogram before and after the radiotherapy

Full Information

First Posted
November 25, 2014
Last Updated
December 20, 2015
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02303197
Brief Title
Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis
Official Title
A Randomized,Controlled Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer patients with radioactive stomatitis. Half of participants will receive ChiNing decoction, while others will receive recombinant human epidermal growth factor (rhEGF) spray.
Detailed Description
This study uses randomized, controlled clinical research methods, through the observation of the treatment group (ChiNing decoction orally) and control group (recombinant human epidermal growth factor rhEGF spray on oral mucosal surface ) at different time points before and after radiotherapy, to evaluate the radiotherapy of acute radiation oral mucosa reaction (RTOG grade), quality of life score (EORTCQLQ-H&N35 scale), oral pain (VAS score) and patient body weight changes of the two groups. At the same time，this study takes cast-off cells of oral mucosal to observe the microscopic characteristics of oral mucosa, and uses the ELISA method to detect IL-6 and TNF- alpha content in the saliva before and after radiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
head and neck cancer, chemoradiotherapy, radioactive stomatitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ChiNing decoction
Arm Type
Experimental
Arm Description
60ml ChiNing decoction by mouth，three times a day for 46 days.
Arm Title
rhEGF spray
Arm Type
No Intervention
Arm Description
The rhEGF spray spray on the oral mucosal surface irradiated area, 3 times a day for 46 days.
Intervention Type
Drug
Intervention Name(s)
ChiNing decoction
Other Intervention Name(s)
Addition and subtraction of Liangge San
Intervention Description
ChiNing decotion was reformed by Liangge San that was stemed from Prescriptions of the Bureau of Taiping People.
Primary Outcome Measure Information:
Title
Grading standard of RTOG in acute radiation injury of oral mucosal
Description
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Time Frame
8 days
Secondary Outcome Measure Information:
Title
The visual analogue scale of oral pain
Description
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Time Frame
8 days
Title
EORTCQLQ-H&N35
Description
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Time Frame
8 days
Title
patient body weight changes
Description
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Time Frame
8 days
Title
Safety index
Description
Chech the blood routine, urine routine, liver and kidney function, electrocardiogram before and after the radiotherapy
Time Frame
2 days
Other Pre-specified Outcome Measures:
Title
IL-6 and TNF- alpha content
Description
With distilled water repeatedly rinse of 1 min, 10 min after discarding the first mouthful of saliva, sit down, spit saliva to the sterile tube in 4 Centigrade， before and after the radiotherapy
Time Frame
2 days
Title
takes cast-off cells of oral mucosal
Description
rinse the mouth with the physiological salt water , scrap sides of buccal oral mucosa 2 times appropriate efforts with appropriate effort, painted on a slide，before and after the radiotherapy
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Head and neck cancer patients with pathology and / or cytologic diagnosis; Age 18~75 years old; The expected life is more than 3 months; The Karnofsky score (Karnofsky) ≥70 points; The first course of radiotherapy in patients; Patients had not received any anti tumour therapies for example of operation, radiotherapy,chemotherapy, biological treatment or isotope therapy system; Patients volunteered to participate in this test and signed the informed consent, understand the purpose and test steps of the test, good compliance, comply with the relevant requirements of this test scheme; No history of oral ulcer and salivary gland diseases Exclusion Criteria: That do not meet the above the inclusion criteria; Advanced critical cases, the expected survival is less than 3 months; The patients had serious complications, such as cachexia, hepatic encephalopathy, gastrointestinal bleeding and coagulation functionobstruction, su ch as abnormal; The submandibular gland pathological changes; During radiotherapy taking other drugs in patients with treatment of stomatitis; The patients with serious heart, brain, liver, kidney function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cong Wang, Master
Organizational Affiliation
National Clinical Research Center for Cancer of China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20921827
Citation
Ryu SH, Kang KM, Moon SY, Chai GY, Hong JP, Cho KO, Kang MI, Choi EK, Lee SW. Therapeutic effects of recombinant human epidermal growth factor (rhEGF) in a murine model of concurrent chemo- and radiotherapy-induced oral mucositis. J Radiat Res. 2010;51(5):595-601. doi: 10.1269/jrr.10069.
Results Reference
background
PubMed Identifier
16258486
Citation
Spielberger R. Current management of oral mucositis. Clin Adv Hematol Oncol. 2005 Oct;3(10):769-71. No abstract available.
Results Reference
background
PubMed Identifier
22679734
Citation
Wang B, Cao SH, Wang YQ. [Effects of modified liangge powder contained serum on LPS stimulated TLR4 expression and release of cytokines in mouse platelets]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2012 May;32(5):681-4. Chinese.
Results Reference
background
PubMed Identifier
16573003
Citation
Yu LZ, Jiang AD, Cheng YY, Lin H, Qin QH, Ma XD. [Liangge san effects the expression of CD14 and scaverger receptor in the Kupffer cells of liver of endotoxemia mice]. Zhongguo Zhong Yao Za Zhi. 2006 Feb;31(3):220-3. Chinese.
Results Reference
background
PubMed Identifier
15958292
Citation
Jiang AD, Yu LZ, Gong XW, Deng P, Ma XD. [Effect of Liangge San on lipopolysaccharide-induced nuclear factor kappa B activation in cultured mouse macrophages]. Di Yi Jun Yi Da Xue Xue Bao. 2005 Jun;25(6):619-22. Chinese.
Results Reference
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Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis

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