Clinical trial · Interventional
Early Use of Opioid in Radiation Mucositis
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
NCT02309437CI-TRIAL-00033789completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nutrition Disorders | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxycodone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mild group
- description
- Use oxycodone when pain is mild level. Start from 10 mg every 12 hours and titrate for appropriate dose.
- interventionNames
- Drug: Oxycodone
- type
- ACTIVE_COMPARATOR
- label
- Moderate group
- description
- Use oxycodone when pain is moderate or severe level. Start from 10 mg every 12 hours and titrate for appropriate dose.
- interventionNames
- Drug: Oxycodone
Primary outcomes (1)
- measure
- Body Mass Index (BMI)
- timeFrame
- Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.