The goal of this study is to compare glutamine combined with thalidomide with glutamine in preventing radiation-induced oral mucositis. The aim of this study is to answer whether glutamine plus thalidomide could improve the median incidence time of grade 2 oral mucositis. Participants would be randomly divided into the two groups above mentioned.
Explore the therapeutic efficacy of glutamine combined with Thalidomide as compared to glutamine alone in preventing radiation-induced oral mucositis. The primary research endpoint is the median time to the onset of Grade II oral mucositis, defined as the number of days from the start of radiation therapy to the occurrence of Grade II oral mucositis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
138
Patients received glutamine combined with thalidomide from the beginning of radiotherapy to one week after radiotherapy.
Patients received glutamine alone from the beginning of radiotherapy to one week after radiotherapy.
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
Median time for the occurrence of Grade 2 radiation-induced oral mucositis
Median time for the occurrence of Grade 2 radiation-induced oral mucositis
Time frame: during radiotherapy up to 4 weeks
incidence rate of ≥grade 3 oral mucositis
incidence rate of ≥grade 3 oral mucositis
Time frame: during radiotherapy up to 4 weeks
Body mass index
\<18.5kg/m2 indicates underweight, 18.5kg/m2-23.9kg/m2 indicates normal weight, \>23.9kg/m2 indicates obesity.
Time frame: during radiotherapy up to 4 weeks
QOL
Out of a total of 60 points, a score less than 20 indicates extremely poor quality of life; 21-30 points indicates poor quality of life; 31-40 points indicates average quality of life; 41-50 points indicates relatively good quality of life; 51-60 points indicates good quality of life.
Time frame: during radiotherapy up to 4 weeks
adverse effects
adverse effects
Time frame: during radiotherapy up to 4 weeks
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