To evaluate the efficacy of GM-CSF to preventing oral mucositis for patients with nasopharyngeal carcinoma receiving radiotherapy.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
138
GM-CSF mouthwash four times per day at radiotherapy initiate, during the whole radiotherapy phase
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe incidence of severe oral mucositis(grade 3+)
To evaluate the incidence of severe oral mucositis between the two arms.
Time frame: During radiotherapy, up to 1.5 months.
Acute toxicities
The incidence rates of acute toxicities during treatment, evaluted by CTCAE Version5.0.
Time frame: One month.
The last time of ≥3 grade oral mucositis
The time from first observed ≥3 grade oral mucositis to first observed oral mucositis decrease to less than grade 3
Time frame: 1 months after radiotherapy
Daily questionaire of oral mucositis (OMDQ)
Patients are required to finish daily questionaire of oral mucositis by visual signs
Time frame: 1 months after radiotherapy
Quality of life(QOL)
QOL is calculated by QLQ-C30.
Time frame: 1 months after radiotherapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.