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

Nutrition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06369961
• Other study ID #: TDFCANCERPAIN20230101
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Chongqing University Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Pain
• Nutrition Disorders

Intervention

Drug:
• transdermal fentanyl
Adult cancer pain patients switched from oral opioid to TDF

Locations

Country	Name	City	State
China	Chao Li	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing University Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Barratt DT, Bandak B, Klepstad P, Dale O, Kaasa S, Christrup LL, Tuke J, Somogyi AA. Genetic, pathological and physiological determinants of transdermal fentanyl pharmacokinetics in 620 cancer patients of the EPOS study. Pharmacogenet Genomics. 2014 Apr;2 — View Citation

Minello C, George B, Allano G, Maindet C, Burnod A, Lemaire A. Assessing cancer pain-the first step toward improving patients' quality of life. Support Care Cancer. 2019 Aug;27(8):3095-3104. doi: 10.1007/s00520-019-04825-x. Epub 2019 May 11. — View Citation

Moryl N, Bokhari A, Griffo Y, Hadler R, Koranteng L, Filkins A, Zheng T, Horn SD, Inturrisi CE. Does transdermal fentanyl work in patients with low BMI? Patient-reported outcomes of pain and percent pain relief in cancer patients on transdermal fentanyl. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	11-point numeric rating scale (NRS) after TDF treatment	Ineffectiveness defined as pain with a NRS of 4 or higher.	in 1 week
Primary	the occasions that breakthrough pain attacks per day after TDF treatment	Ineffectiveness defined as the breakthrough pain attacks more than 3 occasions per day	in 1 week
Primary	The dose adjustment of TDF	Ineffectiveness defined as the dosage of TDF increased	in 1 week
Primary	The kinds of other analgesics combined with TDF	Ineffectiveness defined as more than one kind of analgesics were combined with TDF	in 1 week
Secondary	Adverse effects	Nausea, vomiting, dizziness, rash, constipation, urinary retention, respiratory depression	in 1 week