Status:
COMPLETED
Early Use of Opioid in Radiation Mucositis
Lead Sponsor:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Conditions:
Nutrition Disorders
Quality of Life
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 random...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02309437
Start Date
January 1 2015
End Date
December 31 2017
Last Update
July 17 2018
Active Locations (4)
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1
Cancer Center Of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
2
Guangzhou Panyu Center Hospital
Guangzhou, Guangdong, China, 510000
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
4
People's Hospital of Boluo County
Huizhou, Guangdong, China, 516148