Early Use of Opioid in Radiation Mucositis

July 14, 2018 updated by: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510000
        • Cancer Center of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 510000
        • Guangzhou Panyu Center Hospital
      • Huizhou, Guangdong, China, 516148
        • People's Hospital of Boluo County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • OxyContin
Drug: Oxycodone
Use oxycodone to treat patients with moderate/severe pain caused by radiation mucositis.
Other Names:
  • 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 mild pain caused by radiation mucositis.
Other Names:
  • OxyContin
Drug: Oxycodone
Use oxycodone to treat patients with moderate/severe pain caused by radiation mucositis.
Other Names:
  • OxyContin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

November 29, 2014

First Submitted That Met QC Criteria

December 3, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 14, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAIN-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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