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

NCT02303197 | Completed Phase 3 DMC

• 1 other identifier: TianjinCIH
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; chemoradiotherapy; radioactive stomatitis

Outcome Measures

Primary Outcomes (1)

• 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

  8 days

Secondary Outcomes (4)

• The visual analogue scale of oral pain

  8 days

• EORTCQLQ-H&N35

  8 days

• patient body weight changes

  8 days

• Safety index

  2 days

Other Outcomes (2)

• IL-6 and TNF- alpha content

  2 days

• takes cast-off cells of oral mucosal

  2 days

Study Arms (2)

ChiNing decoction

EXPERIMENTAL

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

Drug: ChiNing decoction

rhEGF spray

NO INTERVENTION

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

Interventions

ChiNing decoction DRUG

ChiNing decotion was reformed by Liangge San that was stemed from Prescriptions of the Bureau of Taiping People.

Also known as: Addition and subtraction of Liangge San

ChiNing decoction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Related Publications (5)

• 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.

  PMID: 20921827 BACKGROUND

• Spielberger R. Current management of oral mucositis. Clin Adv Hematol Oncol. 2005 Oct;3(10):769-71. No abstract available.

  PMID: 16258486 BACKGROUND

• 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.

  PMID: 22679734 BACKGROUND

• 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.

  PMID: 16573003 BACKGROUND

• 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.

  PMID: 15958292 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Cong Wang, Master

  National Clinical Research Center for Cancer of China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: November 27, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 22, 2015

Record last verified: 2014-10

Locations

CN (1)