Brief Title
Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis
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
Brief 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.
Detailed 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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
The incidence of grade II and less oral mucositis at the end of treatment
Secondary Outcome
Pain
Condition
Nasopharyngeal Cancers
Intervention
rhGM-CSF
Study Arms / Comparison Groups
Arm A
Description: Local use of rhGM-CSF + Compound Vitamin B12 solution: 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 solution 5ml being sprayed to mouth five times daily Radiotherapy: Intensity modulated radiation therapy(IMRT) Chemotherapy:Docetaxel or cisplatin weekly or cisplatin once every three weeks during radiotherapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
160
Start Date
March 2013
Completion Date
August 2014
Primary Completion Date
June 2014
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Wei LUO, M.D., +862087343483, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01806272
Organization ID
L-12-01
Responsible Party
Sponsor-Investigator
Study Sponsor
Wei LUO
Study Sponsor
Wei LUO, M.D., Principal Investigator, Sun Yat-sen University
Verification Date
March 2013