Clinical trial NCT02309437: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nutrition Disorders
Quality of Life
Keywords: Nasopharyngeal carcinoma
Pain
Oxycodone
Opioids
Radiation mucositis
Lead sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Secondary outcomes:
measure: Numeric rating scale (NRS)
timeFrame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
measure: Hemoglobin
timeFrame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
measure: Albumin
timeFrame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
measure: Quality of life score
timeFrame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
measure: Dizziness
timeFrame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
measure: Nausea/vomiting
timeFrame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
measure: Somnolence
timeFrame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Panyu Center Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Huizhou
country: China
facility: People's Hospital of Boluo County
state: Guangdong
Study officials:
affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Dong-ping Chen, M. D.
role: STUDY_CHAIR
affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Bin Qi, M. D.
role: STUDY_DIRECTOR
References: