drugset / Trial / NCT03045484

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

NCT03045484

Unknown 70 enrolled Sun Yat-sen University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2016-05
Primary completion
2018-05
Completion
2018-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxycodone Other / unclassified 10 mg Oral