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

A Retrospective Clinical Study on the Impact of Nutritional Status on the Analgesic Effect of Fentanyl Transdermal Patches 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.

Study Overview

• Status: Completed
• Conditions: Nutrition Disorders; Cancer Pain
• Intervention / Treatment: Drug: transdermal fentanyl

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 400030
    • Chao Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Inpatient at the oncology hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Those who used TDF	Drug: transdermal fentanyl; Adult cancer pain patients switched from oral opioid to TDF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
11-point numeric rating scale (NRS) after TDF treatment	Ineffectiveness defined as pain with a NRS of 4 or higher.	in 1 week
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
The dose adjustment of TDF	Ineffectiveness defined as the dosage of TDF increased	in 1 week
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	Nausea, vomiting, dizziness, rash, constipation, urinary retention, respiratory depression	in 1 week

Collaborators and Investigators

• Sponsor: Chongqing University Cancer Hospital
• Investigators: Principal Investigator: Chao Li, Chongqing University Cancer Hospital

Publications and helpful links

General Publications

• 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.
• 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;24(4):185-94. doi: 10.1097/FPC.0000000000000032.
• 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. Cancer Med. 2019 Dec;8(18):7516-7522. doi: 10.1002/cam4.2479. Epub 2019 Sep 30.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nutrition Disorders; Cancer Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: TDFCANCERPAIN20230101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No