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

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ClinicalTrials.gov Identifier: NCT01806272
Recruitment Status : Unknown
Verified March 2013 by Wei LUO, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : March 7, 2013
Last Update Posted : March 29, 2013
Sponsor:
Information provided by (Responsible Party):
Wei LUO, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Cancers Drug: rhGM-CSF Drug: Compound Vitamin B12 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : August 2014


Arm Intervention/treatment
Experimental: Arm A

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.

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.
Other Name: 特尔立

Drug: Compound Vitamin B12
Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily
Other Name: 贯新克

Active Comparator: Arm B

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.

Drug: Compound Vitamin B12
Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily
Other Name: 贯新克




Primary Outcome Measures :
  1. The incidence of grade II and less oral mucositis at the end of treatment [ Time Frame: 7 weeks ]
    Using the criteria of NCI CTCAE v3.0


Secondary Outcome Measures :
  1. Pain [ Time Frame: 12 weeks ]
    Cumulative incidence and time of different grade,using the criteria of WHO,NRS

  2. Cumulative incidence and time of grade III and more oral mucositis [ Time Frame: 7 weeks ]
    Using the criteria of NCI CTCAE v3.0

  3. Dysphagia [ Time Frame: 12 weeks ]
    Cumulative incidence and time of different grade,using NCI CTCAE v3.0

  4. Tumor response to chemoradiotherapy [ Time Frame: 12 weeks ]
    Using the criteria of Response Evaluation Criteria in Solid Tumors1.1(RECIST1.1)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806272


Contacts
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Contact: Wei LUO, M.D. +862087343483 luowei2@mail.sysu.edu.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Wei LUO, M.D.    +862087343483    luowei2@mail.sysu.edu.cn   
Sponsors and Collaborators
Wei LUO
Investigators
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Principal Investigator: Wei LUO, M.D. Sun Yat-sen University
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Responsible Party: Wei LUO, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01806272    
Other Study ID Numbers: L-12-01
First Posted: March 7, 2013    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013
Keywords provided by Wei LUO, Sun Yat-sen University:
rhGM-CSF
Oral Mucositis
Primary Nasopharyngeal Cancers
Chemoradiotherapy
Additional relevant MeSH terms:
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Nasopharyngeal Neoplasms
Nasopharyngeal Carcinoma
Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vitamin B 12
Hydroxocobalamin
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex
Hematinics