Early Use of Opioid in Radiation Mucositis

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University; Affiliated Tumor Hospital of Guangzhou Medical University
• Treatments: Analgesics, Opioid; Oxycodone

Criteria

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.