Early Use of Opioid in Radiation Mucositis

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309437
• Other study ID #: PAIN-1
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2018
• Source: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nutrition Disorders
• Quality of Life

Intervention

Drug:
• Oxycodone
Use oxycodone to treat patients with mild pain caused by radiation mucositis.
• Oxycodone
Use oxycodone to treat patients with moderate/severe pain caused by radiation mucositis.

Locations

Country	Name	City	State
China	Cancer Center Of Guangzhou Medical University	Guangzhou	Guangdong
China	Guangzhou Panyu Center Hospital	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	People's Hospital of Boluo County	Huizhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Secondary	Hemoglobin		Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Secondary	Albumin		Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Secondary	Quality of life score		Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Secondary	Dizziness		Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Secondary	Nausea/vomiting		Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Secondary	Somnolence		Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.