Brain Injuries
Conditions
Brief summary
To investigate the effect of Bevacizumab on asymptomatic radiotherapy-induced brain injury patients with head and neck cancer.
Detailed description
Radiotherapy-induced brain injury (RI) is a serious complication of radiotherapy in head and neck cancer (HNC) patients. Previous studies have confirmed that Bevacizumab has a good effect on patients with symptomatic RI .However, patients with RI maybe do not show clinical symptoms in the early stage. The clinical symptoms will appear with the progression of the RI lesion. There has been no relevant research on whether early intervention is necessary for asymptomatic RI. The investigators conduct this multicenter, randomized clinical research to explore the efficacy and safety of Bevacizumab in asymptomatic RI.
Interventions
DRUGBevacizumab
Bevacizumab 2.5mg/kg, q2w, 4 cycles.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Head MRI confirmed RI lesions. Sign the informed consent.
Exclusion criteria
With clinical symptoms of RI lesions. Head MRI showed bleeding lesions Contraindications of Bevacizumab. Pregnant women and parturient women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence and duration of onset of clinical symptoms. | Change form baseline to evaluation at 1 year. | The incidence and duration of onset of clinical symptoms within 1 year after treatment between the treatment group and the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | Change form baseline to evaluation at 1 year. | the overall survival between the treatment group and the control group. |
| change of RI volume. | Change form baseline to evaluation at 1 year. | The change of RI volume between the treatment group and the control group. |
| change of cognitive function. | Change form baseline to evaluation at 1 year. | The change of cognitive function (MoCa scores) between the treatment group and the control group. The MoCA score ranges from 0 to 30, and higher scores mean a better outcome. |
| change of quality of life. | Change form baseline to evaluation at 1 year. | The change of quality of life ( WHOQOL scale) between the treatment group and the control group. The higher the QOL scores mean a better outcome. |
Countries
China
Contacts
Primary ContactYamei Tang, PHD
Outcome results
None listed