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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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