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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

Tracking Information
First Submitted Date  ICMJE March 4, 2013
First Posted Date  ICMJE March 7, 2013
Last Update Posted Date March 29, 2013
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
  • Pain [ Time Frame: 12 weeks ]
    Cumulative incidence and time of different grade,using the criteria of WHO,NRS
  • Cumulative incidence and time of grade III and more oral mucositis [ Time Frame: 7 weeks ]
    Using the criteria of NCI CTCAE v3.0
  • Dysphagia [ Time Frame: 12 weeks ]
    Cumulative incidence and time of different grade,using NCI CTCAE v3.0
  • Tumor response to chemoradiotherapy [ Time Frame: 12 weeks ]
    Using the criteria of Response Evaluation Criteria in Solid Tumors1.1(RECIST1.1)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Cancers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: rhGM-CSF
    • Drug: Compound Vitamin B12
  • 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.

    Intervention: Drug: Compound Vitamin B12
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 6, 2013)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01806272
Other Study ID Numbers  ICMJE L-12-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wei LUO, Sun Yat-sen University
Study Sponsor  ICMJE Wei LUO
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wei LUO, M.D. Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP