Early Use of Opioid in Radiation Mucositis

NCT02309437 | Completed Phase 2

• 1 other identifier: PAIN-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Nutrition Disorders; Quality of Life

Keywords

Nasopharyngeal carcinoma; Pain; Oxycodone; Opioids; Radiation mucositis

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (7)

• Numeric rating scale (NRS)

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

• 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.

Study Arms (2)

Mild group

EXPERIMENTAL

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

Drug: Oxycodone

Moderate group

ACTIVE COMPARATOR

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

Drug: Oxycodone

Interventions

Oxycodone DRUG

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

Also known as: OxyContin

Mild group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead

Study Sites (4)

Cancer Center Of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

Guangzhou Panyu Center Hospital

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

People's Hospital of Boluo County

Huizhou, Guangdong, 516148, China

Location

MeSH Terms

Conditions

Nutrition Disorders; Nasopharyngeal Carcinoma; Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Dong-ping Chen, M. D.

  Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  STUDY CHAIR

• Bin Qi, M. D.

  Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2014
• First Posted: December 5, 2014
• Study Start: January 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)