Early Use of Opioid in Radiation Mucositis

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Status and phase: Completed; Phase 2

Conditions: Nutrition Disorders; Quality of Life

Treatments: Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT02309437

PAIN-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Mild group

Experimental group

Description:

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

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Moderate group

Active Comparator group

Description:

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

Treatment:

Drug: Oxycodone

Drug: Oxycodone