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NCT Number: NCT06369961

Correlation Between the Analgesic Effect of Fentanyl Transdermal Patches and Nutritional Status in Cancer Pain Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chao Li

Chongqing, 400030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

transdermal fentanyl

Drug

Adult cancer pain patients switched from oral opioid to TDF

Primary outcomes

  1. 11-point numeric rating scale (NRS) after TDF treatment

    Time frame: in 1 week

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

  2. the occasions that breakthrough pain attacks per day after TDF treatment

    Time frame: in 1 week

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

  3. The dose adjustment of TDF

    Time frame: in 1 week

    Ineffectiveness defined as the dosage of TDF increased

  4. The kinds of other analgesics combined with TDF

    Time frame: in 1 week

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

Secondary outcomes

  1. Adverse effects

    Time frame: in 1 week

    Nausea, vomiting, dizziness, rash, constipation, urinary retention, respiratory depression

Sponsors and collaborators

Lead sponsor

Chongqing University Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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