This study is a superiority research to evaluate the safety and effectiveness of early use of oxycodone control release tablet for radiation mucositis in nasopharyngeal carcinoma patients.
The present study is a prospective, randomizing, case-controlled, multi-center clinical trial. 174 firstly diagnosed nasopharyngeal carcinoma patients who need radical radiation therapy will be randomly divided into either early intervention or common intervention group. oxycodone control release tablets will be used to control the pain caused by radiation oral mucositis when the pain level is mild or moderate, respectively. The primary outcome measurement is nutrition status. Quality of life (QOL), the clinical outcomes, and the adverse effects are also to be observed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
200
Cancer Center Of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangzhou Panyu Center Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
People's Hospital of Boluo County
Huizhou, Guangdong, China
Body Mass Index (BMI)
Body mass index (BMI, kg/m2) was defined as the body mass (kg) divided by the square of the body height (m).
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Numeric rating scale (NRS)
NRS refers to the number 0-10 to indicate the degree of pain, 0 is painless and 10 is the most painful.
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Hemoglobin
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Albumin
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Quality of life score
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Dizziness
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Nausea/vomiting
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Somnolence
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
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