Comparison of Oxycodone to Control Moderate or Severe Oral Mucositis Pain Induced by Chemoradiotherapy

Study Overview
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Brief Summary
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Background:Although concurrent chemoradiotherapy is effective for improving disease-free survival and overall survival in patients with locally advanced nasopharyngeal carcinoma. However,the oral mucositis pain evoked by the chemoradiotherapy itself reduces food intake and frequently halts the treatment. Thus, pain control is an important problem in chemoradiotherapy for nasopharyngeal carcinoma.We performed to examine whether early induction of low-dose, opioid from moderate pain reduced total dose of Oxycodone during chemoradiotherapy, while improves the quality of life and reduce weight loss. Objective:Present clinical trial to investigate the early introduction of opioids suppressed the transient increase in the numeric rating scales(NRS) score for pain and compared with conventional treatment. Methodology:The subjects will recruit 70 patients who were hospitalized for nasopharyngeal carcinoma. 70 patients were divided into two groups, depending on whether the pain was moderate or severe when an opioid was introduced.Differences between groups were compared using T test protected least significant difference for one-factor analysis of variance. All statistical analyses were performed using SPSS(Statistic Package for Social Science) software.P-values < 0.05 were considered statistically significant.

Detailed Description
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Controlled-release oxycodone (CRO) was used in this study. The patients kept a daily record of the intensity of pain. CRO is effective for 12 h, so that the patient takes it only twice a day.The minimum oral unit of CRO is a 10 mg tablet, so the minimum daily dose was 20 mg. Thus, we began at a dose of 20 mg by default. When the pain worsened, the dose was quickly titrated.When a patient who was suffering from moderate pain in the mouth, pharynx, or larynx consented to take oxycodone, oxycodone was begun at the level of moderate pain. We called this the mild group. In contrast, those patients who did not ask for oxycodone until the pain reached a severe level were called the severe group. Because all patients agreed to use an opioid at some point, the patients were classified into two groups, moderate and severe, according to when the opioid was introduced. Total dose of oxycodone was defined as the total dose of oxycodone taking during the treatment of chemoradiotherapy. Pain Remission Rate was defined as pain remission after 24h from the start of opioid administration.Evaluating quality of life were conducted once every two weeks.We also evaluated the weight loss as parameters for food intake once a week,until the radiotherapy.All statistical analyses were performed using SPSS software.

Official Title
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Comparison of Controlled-release Oxycodone to Control Chemoradiotherapy-induced Moderate or Severe Oral Mucositis Pain in Nasopharyngeal Carcinoma Patients

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Controlled-release oxycodone
* Other: Chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Age 18 to 65 years. Patients of both genders must be willing to practice birth control from the time of enrollment on this study. Participants with treatment- Chemoradiotherapy advanced Nasopharyngeal carcinoma. Participants with the ability to assess the pain level. Never use a opioid before treatment. Hematology: WBC≥4.0×109/L, ANC≥1.5×109/L, PLT≥100×109/L,Hb≥90g/L. Exclusion Criteria: •Patients do not conform to the inclusion criteria. Refuse to use of opioid drugs. Nasopharyngeal patients with mental illness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The moderate group<br>Patient who was suffering from moderate pain in the mouth, pharynx, or larynx during the treatment of chemoradiotherapy consented to take controlled-release oxycodone, oxycodone was begun at the level of mild pain. We called this the moderate group. Controlled-release oxycodone was used to relieve oral mucositis pain induced by chemoradiotherapy in this group. | Drug: Controlled-release oxycodone<br>* CRO is effective for 12 h. Patient takes it only twice a day. The minimum oral unit of CRO is a 10 mg tablet, so the minimum daily dose was 10 mg.<br>* Other names: CRO;Other: Chemoradiotherapy<br>* Radiotherapy were administered intensity modulated radiation therapy wiht a dose of 1.8-2.2Gy per fraction, 30-32 fraction for various tumor locations. Chemotherapy drugs platinum was used once a weak with 100mg/㎡.<br>* Other names: Radiotherapy and Chemotherapy;|
| Experimental: The severe group<br>Patients who did not ask for controlled-release oxycodone until the pain reached a moderate level during the treatment of chemoradiotherapywere called the severe group. Controlled-release oxycodone was also used to relieve oral mucositis pain induced by chemoradiotherapy in this group.. | Drug: Controlled-release oxycodone<br>* CRO is effective for 12 h. Patient takes it only twice a day. The minimum oral unit of CRO is a 10 mg tablet, so the minimum daily dose was 10 mg.<br>* Other names: CRO;Other: Chemoradiotherapy<br>* Radiotherapy were administered intensity modulated radiation therapy wiht a dose of 1.8-2.2Gy per fraction, 30-32 fraction for various tumor locations. Chemotherapy drugs platinum was used once a weak with 100mg/㎡.<br>* Other names: Radiotherapy and Chemotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Dose of Oxycodone |  | Through chemoradiotherapy completion, 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Remission Rate |  | 24 hours | 
| Quality-of-Life Index |  | Through chemoradiotherapy completion, an average of 2 weaks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasopharyngeal carcinoma, Oral Mucositis Pain, Oxycodone