Nasopharyngeal Carcinoma Clinical Trial
Official title:
Comparison of Controlled-release Oxycodone to Control Chemoradiotherapy-induced Moderate or Severe Oral Mucositis Pain in Nasopharyngeal Carcinoma Patients
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.
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.
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