Early Use of Opioid in Radiation Mucositis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influences on the Nutrition Statuses and Clinical Outcomes of Early Use of Opioid to Control Local Mucosa Pain Induced by Irradiation in Nasopharyngeal Carcinoma Patients

Conditions
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Nutrition Disorders, Quality of Life

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological confirmed nasopharyngeal carcinoma; Without historic chronic pain, no depend on analgesic drugs, no historic opioids intake; Plan to receive radical radiation therapy, newly to radiation for head and neck; Aged older or equal to 18 years old; Could understand and cooperate to accomplish pain evaluation and observation scales; 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; Without other serious critical organ dysfunction, such as heart or lung dysfunction; Performance status (PS) score less than 2; Voluntary to participate and sign informed consent document; Obey the rules of trail; could be followed-up on time. Exclusion Criteria: Excluded by inclusion criteria; Known or suspected allergy to nonsteroidal anti-inflammatory drug (NSAID) or opioid medicine; Unable to complete the follow-up; Severe uncontrollable infections of medical disorders; Major organ including heart, lung, kidney, or liver dysfunction; With pathophysiological factors affecting drug absorption, distribution, metabolism or excretion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild group<br>Use oxycodone when pain is mild level. Start from 10 mg every 12 hours and titrate for appropriate dose. | Drug: Oxycodone<br>* Use oxycodone to treat patients with mild pain caused by radiation mucositis.<br>* Other names: OxyContin;|
| Active Comparator: Moderate group<br>Use oxycodone when pain is moderate or severe level. Start from 10 mg every 12 hours and titrate for appropriate dose. | Drug: Oxycodone<br>* Use oxycodone to treat patients with moderate/severe pain caused by radiation mucositis.<br>* Other names: OxyContin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal carcinoma, Pain, Oxycodone, Opioids, Radiation mucositis