Nutrition Disorders, Quality of Life
Conditions
Keywords
Nasopharyngeal carcinoma, Pain, Oxycodone, Opioids, Radiation mucositis
Brief summary
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.
Detailed description
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.
Interventions
DRUGOxycodone
Use oxycodone to treat patients with mild pain caused by radiation mucositis.
Sponsors
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histological confirmed nasopharyngeal carcinoma; 2. Without historic chronic pain, no depend on analgesic drugs, no historic opioids intake; 3. Plan to receive radical radiation therapy, newly to radiation for head and neck; 4. Aged older or equal to 18 years old; 5. Could understand and cooperate to accomplish pain evaluation and observation scales; 6. Sufficient liver and kidney function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5\* upper limit of normal (ULN), serum creatinine less than 1.5\*ULN; 7. Without other serious critical organ dysfunction, such as heart or lung dysfunction; 8. Performance status (PS) score less than 2; 9. Voluntary to participate and sign informed consent document; 10. Obey the rules of trail; could be followed-up on time.
Exclusion criteria
1. Excluded by inclusion criteria; 2. Known or suspected allergy to nonsteroidal anti-inflammatory drug (NSAID) or opioid medicine; 3. Unable to complete the follow-up; 4. Severe uncontrollable infections of medical disorders; 5. Major organ including heart, lung, kidney, or liver dysfunction; 6. With pathophysiological factors affecting drug absorption, distribution, metabolism or excretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. | Body mass index (BMI, kg/m2) was defined as the body mass (kg) divided by the square of the body height (m). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | 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. | — |
| Numeric rating scale (NRS) | Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. | NRS refers to the number 0-10 to indicate the degree of pain, 0 is painless and 10 is the most painful. |
| 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. | — |
| Dizziness | Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. | — |
Countries
China
Outcome results
None listed