NCT06472739

The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy

The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy: A Single-center, Phase II, Randomized Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of GM-CSF to preventing oral mucositis for patients with nasopharyngeal carcinoma receiving radiotherapy.

Detailed description

Patients of GM-CSF group receive GM-CSF washmouth four times a day during radiotherapy. Control arm receive conventioanl care during radiotherapy. Visual signs of radiation or chemotherapy-induced mucosal damage were independently assessed during the course of RT by a radiation oncologist or other trained study personnel. The incidence of severe oral mucositis, the severe oral mucositis last time, quality of life between the two arms would be calculated.

Conditions

• GM-CSF

Interventions

Type	Name	Description
DRUG	GM-CSF	GM-CSF mouthwash four times per day at radiotherapy initiate, during the whole radiotherapy phase

Timeline

• Start date: 2023-09-15
• Primary completion: 2024-08-15
• Completion: 2024-11-15
• First posted: 2024-06-25
• Last updated: 2024-06-25

Locations

1 site across 1 country: China