Suspended

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

What is being tested

rhGM-CSF

+ Compound Vitamin B12

Drug

Who is being recruted

Head and Neck Neoplasms+9

+ Stomatognathic Diseases

+ Mouth Diseases

From 18 to 65 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: March 2013

See protocol details

Summary

Principal SponsorWei LUO

Study ContactWei LUO, M.D.More contacts

Last updated: March 29, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

Inclusion Criteria: Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma. Receiving 68-72 Gray of radiation dose. Age between 18 and 65 years. KPS≥70. Patient who has given his/her written consent before any specific procedure of the protocol. Exclusion Criteria: Severe uncontrolled infection. Pregnant or breast-feeding females. Allergy to this medicine. Diarrhea. Outcome measures: Grade of oral mucositis:NCI Common Terminology Criteria for Adverse Events v3.0, NCI CTCAE v3.0 Pain: WHO,Numerical Rating Scale(NRS) Tumor response to chemoradiotherapy:Response Evaluation Criteria in Solid Tumors,RECIST1.1

NCT01806272

Principal SponsorWei LUO

Study ContactWei LUO, M.D.More contacts

Last updated: March 29, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Head and Neck NeoplasmsStomatognathic DiseasesMouth DiseasesNasopharyngeal DiseasesNeoplasmsNeoplasms by SiteOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsPharyngeal DiseasesPharyngeal NeoplasmsNasopharyngeal NeoplasmsStomatitis

Criteria

5 inclusion criteria required to participate

Age between 18 and 65 years

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

KPS >= 70

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

Show More Criteria

4 exclusion criteria prevent from participating

Allergy to this medicine

Diarrhea

Pregnant or breast-feeding females

Severe uncontrolled infection

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Group II

Active Comparator

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Sun Yat-sen University Cancer Center

Guangzhou, ChinaOpen Sun Yat-sen University Cancer Center in Google Maps

SuspendedOne Study Center