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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild group | Experimental | Use oxycodone when pain is mild level. Start from 10 mg every 12 hours and titrate for appropriate dose. |
|
| Moderate group | Active Comparator | Use oxycodone when pain is moderate or severe level. Start from 10 mg every 12 hours and titrate for appropriate dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | Use oxycodone to treat patients with mild pain caused by radiation mucositis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. |
| Hemoglobin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong-ping Chen, M. D. | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Study Chair |
| Bin Qi, M. D. | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center Of Guangzhou Medical University | Guangzhou | Guangdong | 510000 | China | ||
| Guangzhou Panyu Center Hospital |
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| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D000077274 | Nasopharyngeal Carcinoma |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Oxycodone | Drug | Use oxycodone to treat patients with moderate/severe pain caused by radiation mucositis. |
|
|
| Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. |
| Albumin | Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. |
| Quality of life score | Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. |
| Dizziness | Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. |
| Nausea/vomiting | Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. |
| Somnolence | Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. |
| Guangzhou |
| Guangdong |
| 510000 |
| China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
| People's Hospital of Boluo County | Huizhou | Guangdong | 516148 | China |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |