NCT02309437

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nutrition Disorders
• Quality of Life

Interventions

Type	Name	Description
DRUG	Oxycodone	Use oxycodone to treat patients with mild pain caused by radiation mucositis.
DRUG	Oxycodone	Use oxycodone to treat patients with moderate/severe pain caused by radiation mucositis.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2014-12-05
• Last updated: 2018-07-17

Locations

4 sites across 1 country: China