Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2015-01-01
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Mild group
Use oxycodone when pain is mild level. Start from 10 mg every 12 hours and titrate for appropriate dose.
Oxycodone
Use oxycodone to treat patients with mild pain caused by radiation mucositis.
Moderate group
Use oxycodone when pain is moderate or severe level. Start from 10 mg every 12 hours and titrate for appropriate dose.
Oxycodone
Use oxycodone to treat patients with moderate/severe pain caused by radiation mucositis.
Interventions
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Oxycodone
Use oxycodone to treat patients with mild pain caused by radiation mucositis.
Oxycodone
Use oxycodone to treat patients with moderate/severe pain caused by radiation mucositis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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.
18 Years
ALL
No
Sponsors
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Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Dong-ping Chen, M. D.
Role: STUDY_CHAIR
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Bin Qi, M. D.
Role: STUDY_DIRECTOR
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Locations
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Cancer Center Of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangzhou Panyu Center Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
People's Hospital of Boluo County
Huizhou, Guangdong, China
Countries
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Other Identifiers
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PAIN-1
Identifier Type: -
Identifier Source: org_study_id
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