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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

Tracking Information
First Submitted Date  ICMJE November 29, 2014
First Posted Date  ICMJE December 5, 2014
Last Update Posted Date July 17, 2018
Actual Study Start Date  ICMJE January 1, 2015
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
Body Mass Index (BMI) [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
Change History Complete list of historical versions of study NCT02309437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2018)
  • 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.
  • Hemoglobin [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  • Albumin [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  • Quality of life score [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  • Dizziness [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  • Nausea/vomiting [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  • Somnolence [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
  • Numeric rating scale (NRS) [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  • Hemoglobin [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  • Albumin [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  • Quality of life score [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  • Dizziness [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  • Nausea/vomiting [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
  • Somnolence [ Time Frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Use of Opioid in Radiation Mucositis
Official Title  ICMJE 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
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Nutrition Disorders
  • Quality of Life
Intervention  ICMJE
  • Drug: Oxycodone
    Use oxycodone to treat patients with mild pain caused by radiation mucositis.
    Other Name: OxyContin
  • Drug: Oxycodone
    Use oxycodone to treat patients with moderate/severe pain caused by radiation mucositis.
    Other Name: OxyContin
Study Arms  ICMJE
  • Experimental: Mild group
    Use oxycodone when pain is mild level. Start from 10 mg every 12 hours and titrate for appropriate dose.
    Intervention: Drug: Oxycodone
  • 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.
    Intervention: Drug: Oxycodone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2018)
200
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2014)
174
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02309437
Other Study ID Numbers  ICMJE PAIN-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study Sponsor  ICMJE Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP