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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01806272

Enrollment

160

Registered

2013-03-07

Start date

2013-03-31

Completion date

2014-08-31

Last updated

2013-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Cancers

Keywords

rhGM-CSF, Oral Mucositis, Primary Nasopharyngeal Cancers, Chemoradiotherapy

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

Interventions

DRUGrhGM-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.

DRUGCompound Vitamin B12

Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The incidence of grade II and less oral mucositis at the end of treatment	7 weeks	Using the criteria of NCI CTCAE v3.0

Secondary

Measure	Time frame	Description
Pain	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	7 weeks	Using the criteria of NCI CTCAE v3.0
Dysphagia	12 weeks	Cumulative incidence and time of different grade,using NCI CTCAE v3.0
Tumor response to chemoradiotherapy	12 weeks	Using the criteria of Response Evaluation Criteria in Solid Tumors1.1(RECIST1.1)

Countries

China

Contacts

Primary ContactWei LUO, M.D.

luowei2@mail.sysu.edu.cn+862087343483

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026