Early Use of Opioid in Radiation Mucositis

Phase 2

Completed

• Conditions: Nutrition Disorders; Quality of Life
• Interventions: Drug: Oxycodone

• Registration Number: NCT02309437
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-11-29
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-05
• Study Start: 2015-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-14
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate group	Oxycodone	Use oxycodone when pain is moderate or severe level. Start from 10 mg every 12 hours and titrate for appropriate dose.
Mild group	Oxycodone	Use oxycodone when pain is mild level. Start from 10 mg every 12 hours and titrate for appropriate dose.

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	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

Name	Time	Method
Numeric rating scale (NRS)	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	Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Albumin	Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Quality of life score	Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Dizziness	Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Nausea/vomiting	Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Somnolence	Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

Trial Locations

Locations (4)

People's Hospital of Boluo County; 🇨🇳 Huizhou, Guangdong, China

Guangzhou Panyu Center Hospital; 🇨🇳 Guangzhou, Guangdong, China

Cancer Center Of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China