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Early Use of Opioid in Radiation Mucositis

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ClinicalTrials.gov Identifier: NCT02309437
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Nutrition Disorders Quality of Life Drug: Oxycodone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mild group
Use oxycodone when pain is mild level. Start from 10 mg every 12 hours and titrate for appropriate dose.
Drug: Oxycodone
Use oxycodone to treat patients with mild pain caused by radiation mucositis.
Other Name: OxyContin

Active Comparator: Moderate group
Use oxycodone when pain is moderate or severe level. Start from 10 mg every 12 hours and titrate for appropriate dose.
Drug: Oxycodone
Use oxycodone to treat patients with moderate/severe pain caused by radiation mucositis.
Other Name: OxyContin




Primary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
    Body mass index (BMI, kg/m2) was defined as the body mass (kg) divided by the square of the body height (m).


Secondary Outcome Measures :
  1. Numeric rating scale (NRS) [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
    NRS refers to the number 0-10 to indicate the degree of pain, 0 is painless and 10 is the most painful.

  2. Hemoglobin [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  3. Albumin [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  4. Quality of life score [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  5. Dizziness [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  6. Nausea/vomiting [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  7. Somnolence [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309437


Locations
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China, Guangdong
Cancer Center Of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
Guangzhou Panyu Center Hospital
Guangzhou, Guangdong, China, 510000
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
People's Hospital of Boluo County
Huizhou, Guangdong, China, 516148
Sponsors and Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Investigators
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Study Chair: Dong-ping Chen, M. D. Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study Director: Bin Qi, M. D. Affiliated Cancer Hospital & Institute of Guangzhou Medical University

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Responsible Party: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02309437     History of Changes
Other Study ID Numbers: PAIN-1
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Affiliated Cancer Hospital & Institute of Guangzhou Medical University:
Nasopharyngeal carcinoma
Pain
Oxycodone
Opioids
Radiation mucositis

Additional relevant MeSH terms:
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Oxycodone
Nasopharyngeal Carcinoma
Nutrition Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents