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临床试验/NCT06369961
NCT06369961已完成不适用

A Retrospective Clinical Study on the Impact of Nutritional Status on the Analgesic Effect of Fentanyl Transdermal Patches in Cancer Pain Patients

Chongqing University Cancer Hospital1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2023年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
151
试验地点
1
主要终点
11-point numeric rating scale (NRS) after TDF treatment

研究概览

简要总结

The goal of this observational study is to investigate the correlation and quantitative relationship between the analgesic effect of fentanyl transdermal patches in cancer pain patients and their nutritional status.

详细描述

Cancer-related pain is one of the most common and unbearable symptoms among patients with malignant tumors. Opioids are commonly used to treat moderate or severe cancer pain. Among them, fentanyl is a synthetic opioid with analgesic adjuvant with a 50~100 times higher potency than morphine. Due to its small molecular weight, high lipid solubility, and low irritation to the skin, transdermal fentanyl (TDF) is formulated, which is more convenient for patients with intestinal obstruction, swallowing difficulties, and intolerance to oral opioids. According to some research, the TDF demonstrated good cancer pain control for patients switching from morphine or oral oxycodone preparations, and was well tolerated.

However, a part of patients still go through increased breakthrough pain, sleep disturbances, and even accompanied by anxiety and depression when using TDF. Therefore, early identification of cancer pain patients using TDF at risk of ineffectiveness is an essential step in increasing analgesic effectiveness, and improving quality of life.

Some studies discovered different clinical factors such as age, gender, serum albumin, glomerular filtration rate, kidney disease, body mass index (BMI), total protein, alanine aminotransferases have some influence on fentanyl serum concentration and the dose of TDF. Furthermore, the clinical factors seem to have a greater impact on the effectiveness of TDF than the genetic factors which may affect the liver metabolism of fentanyl. Based on these results, we aim to investigate the correlation and quantitative relationship between the analgesic effect of fentanyl transdermal patches in cancer pain patients and their nutritional status. Our purpose is to help clinicians recognize and increase the analgesic effect of TDF according to the patient's risk level.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cancer pain patients admitted to our hospital;
  • Cancer pain patients switched from oral sustained-release strong opioid analgesics to fentanyl transdermal patches during the hospital stay.

排除标准

  • Patients who have been switched to fentanyl transdermal patches after titration with an analgesic pump;
  • Patients using fentanyl transdermal patches in combination with other oral sustained-release strong opioid analgesics;
  • Patients using fentanyl transdermal patches in combination with an analgesic pump;
  • Patients who have used fentanyl transdermal patches for less than 3 days;
  • Patients with postoperative pain;
  • Patients with allergies;
  • Patients who are pregnant women;
  • Patients with missing data.

研究组 & 干预措施

Group A

Those who used TDF

干预措施: transdermal fentanyl (Drug)

结局指标

主要结局

11-point numeric rating scale (NRS) after TDF treatment

时间窗: in 1 week

Ineffectiveness defined as pain with a NRS of 4 or higher.

the occasions that breakthrough pain attacks per day after TDF treatment

时间窗: in 1 week

Ineffectiveness defined as the breakthrough pain attacks more than 3 occasions per day

The dose adjustment of TDF

时间窗: in 1 week

Ineffectiveness defined as the dosage of TDF increased

The kinds of other analgesics combined with TDF

时间窗: in 1 week

Ineffectiveness defined as more than one kind of analgesics were combined with TDF

次要结局

  • Adverse effects(in 1 week)

研究者

发起方
Chongqing University Cancer Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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