Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis

Nasopharyngeal Cancers Clinical Trial

Official title:

A Open,Randomized Phase II Trial Comparing Local Use of rhGM-CSF and Compound Vitamin B12 Solution to Compound Vitamin B12 Solution Alone Treating Chemoradiotherapy-induced Oral Mucositis in Patients With Primary Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01806272
• Other study ID #: L-12-01
• Status: Recruiting
• Phase: Phase 2
• First received: March 4, 2013
• Last updated: March 27, 2013
• Start date: March 2013
• Est. completion date: August 2014

Study information

• Verified date: March 2013
• Source: Sun Yat-sen University
• Contact: Wei LUO, M.D.
• Phone: +862087343483
• Email: luowei2[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a open,randomized phase II trial comparing effectiveness and safety of local use of rhGM-CSF and Compound Vitamin B12 to Compound Vitamin B12 solution alone treating oral mucositis in primary nasopharyngeal cancer. The main end point is the incidence of grade II and less oral mucositis at the end of treatment.The hypothesis of the study is that the local use of rhGM-CSF and Compound Vitamin B12 can decrease the incidence of grade III and more oral mucositis at the end of treatment compared to local use of Compound Vitamin B12 alone.

Description:

Inclusion Criteria:

1. Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma.

2. Receiving 68-72 Gray of radiation dose.

3. Age between 18 and 65 years.

4. KPS≥70.

5. Patient who has given his/her written consent before any specific procedure of the protocol.

Exclusion Criteria:

1. Severe uncontrolled infection.

2. Pregnant or breast-feeding females.

3. Allergy to this medicine.

4. Diarrhea.

Outcome measures:

1. Grade of oral mucositis:NCI Common Terminology Criteria for Adverse Events v3.0, NCI CTCAE v3.0

2. Pain: WHO,Numerical Rating Scale(NRS)

3. Tumor response to chemoradiotherapy:Response Evaluation Criteria in Solid Tumors,RECIST1.1

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma.

2. Receiving 68-72 Gray of radiation dose.

3. Age between 18 and 65 years.

4. KPS=70.

5. Patient who has given his/her written consent before any specific procedure of the protocol.

Exclusion Criteria:

1. Severe uncontrolled infection.

2. Pregnant or breast-feeding females.

3. Allergy to this medicine.

4. Diarrhea.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mucositis
• Nasopharyngeal Cancers
• Stomatitis

Intervention

Drug:
• rhGM-CSF
The rhGM-CSF is prepared as a mouthwash solution,diluting 150µg in 100ml water(final concentration of 1.5µg/ml).Patient is instructed to use the solution five times daily.
• Compound Vitamin B12
Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Wei LUO

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of grade II and less oral mucositis at the end of treatment	Using the criteria of NCI CTCAE v3.0	7 weeks	Yes
Secondary	Pain	Cumulative incidence and time of different grade,using the criteria of WHO,NRS	12 weeks	Yes
Secondary	Cumulative incidence and time of grade III and more oral mucositis	Using the criteria of NCI CTCAE v3.0	7 weeks	Yes
Secondary	Dysphagia	Cumulative incidence and time of different grade,using NCI CTCAE v3.0	12 weeks	Yes
Secondary	Tumor response to chemoradiotherapy	Using the criteria of Response Evaluation Criteria in Solid Tumors1.1(RECIST1.1)	12 weeks	No