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Early Use of Opioid in Radiation Mucositis

Primary Purpose

Nutrition Disorders, Quality of Life

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Oxycodone

About this trial

This is an interventional supportive care trial for Nutrition Disorders focused on measuring Nasopharyngeal carcinoma, Pain, Oxycodone, Opioids, Radiation mucositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histological confirmed nasopharyngeal carcinoma;
Without historic chronic pain, no depend on analgesic drugs, no historic opioids intake;
Plan to receive radical radiation therapy, newly to radiation for head and neck;
Aged older or equal to 18 years old;
Could understand and cooperate to accomplish pain evaluation and observation scales;
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;
Without other serious critical organ dysfunction, such as heart or lung dysfunction;
Performance status (PS) score less than 2;
Voluntary to participate and sign informed consent document;
Obey the rules of trail; could be followed-up on time.

Exclusion Criteria:

Excluded by inclusion criteria;
Known or suspected allergy to nonsteroidal anti-inflammatory drug (NSAID) or opioid medicine;
Unable to complete the follow-up;
Severe uncontrollable infections of medical disorders;
Major organ including heart, lung, kidney, or liver dysfunction;
With pathophysiological factors affecting drug absorption, distribution, metabolism or excretion.

Sites / Locations

Cancer Center Of Guangzhou Medical University
Guangzhou Panyu Center Hospital
Sun Yat-sen University Cancer Center
People's Hospital of Boluo County

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mild group

Moderate group

Arm Description

Use oxycodone when pain is mild level. Start from 10 mg every 12 hours and titrate for appropriate dose.

Use oxycodone when pain is moderate or severe level. Start from 10 mg every 12 hours and titrate for appropriate dose.

Outcomes

Primary Outcome Measures

Body Mass Index (BMI)

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

Numeric rating scale (NRS)

NRS refers to the number 0-10 to indicate the degree of pain, 0 is painless and 10 is the most painful.

Hemoglobin

Albumin

Quality of life score

Dizziness

Nausea/vomiting

Somnolence

Full Information

NCT ID

NCT02309437

First Posted

November 29, 2014

Last Updated

July 14, 2018

Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02309437

Brief Title

Early Use of Opioid in Radiation Mucositis

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

January 1, 2015 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nutrition Disorders, Quality of Life

Keywords

Nasopharyngeal carcinoma, Pain, Oxycodone, Opioids, Radiation mucositis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mild group

Arm Type

Experimental

Arm Description

Use oxycodone when pain is mild level. Start from 10 mg every 12 hours and titrate for appropriate dose.

Arm Title

Moderate group

Arm Type

Active Comparator

Arm Description

Use oxycodone when pain is moderate or severe level. Start from 10 mg every 12 hours and titrate for appropriate dose.

Intervention Type

Drug

Intervention Name(s)

Oxycodone

Other Intervention Name(s)

OxyContin

Intervention Description

Use oxycodone to treat patients with mild pain caused by radiation mucositis.

Intervention Type

Drug

Intervention Name(s)

Oxycodone

Other Intervention Name(s)

OxyContin

Intervention Description

Use oxycodone to treat patients with moderate/severe pain caused by radiation mucositis.

Primary Outcome Measure Information:

Title

Body Mass Index (BMI)

Description

Body mass index (BMI, kg/m2) was defined as the body mass (kg) divided by the square of the body height (m).

Time Frame

Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

Secondary Outcome Measure Information:

Title

Numeric rating scale (NRS)

Description

NRS refers to the number 0-10 to indicate the degree of pain, 0 is painless and 10 is the most painful.

Time Frame

Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

Title

Hemoglobin

Time Frame

Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

Title

Albumin

Time Frame

Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

Title

Quality of life score

Time Frame

Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

Title

Dizziness

Time Frame

Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

Title

Nausea/vomiting

Time Frame

Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

Title

Somnolence

Time Frame

Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological confirmed nasopharyngeal carcinoma; Without historic chronic pain, no depend on analgesic drugs, no historic opioids intake; Plan to receive radical radiation therapy, newly to radiation for head and neck; Aged older or equal to 18 years old; Could understand and cooperate to accomplish pain evaluation and observation scales; 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; Without other serious critical organ dysfunction, such as heart or lung dysfunction; Performance status (PS) score less than 2; Voluntary to participate and sign informed consent document; Obey the rules of trail; could be followed-up on time. Exclusion Criteria: Excluded by inclusion criteria; Known or suspected allergy to nonsteroidal anti-inflammatory drug (NSAID) or opioid medicine; Unable to complete the follow-up; Severe uncontrollable infections of medical disorders; Major organ including heart, lung, kidney, or liver dysfunction; With pathophysiological factors affecting drug absorption, distribution, metabolism or excretion.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dong-ping Chen, M. D.

Organizational Affiliation

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Bin Qi, M. D.

Organizational Affiliation

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Cancer Center Of Guangzhou Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Facility Name

Guangzhou Panyu Center Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Facility Name

People's Hospital of Boluo County

City

Huizhou

State/Province

Guangdong

ZIP/Postal Code

516148

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Early Use of Opioid in Radiation Mucositis

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