CompletedNCT06369961Updated Apr 17, 2024

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

An observational study in Cancer Pain and Nutrition Disorders, sponsored by Chongqing University Cancer Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by Chongqing University Cancer Hospital · Observational

Study type: Observational
Model: Case-only
Time perspective: Retrospective
Enrollment: 151
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Cancer Pain
Nutrition Disorders

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In context

Nutrition Disorders

275 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.

This study's enrollment of 151 is above the median of 108 across 74 observational studies indexed under Nutrition Disorders.

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Lead sponsor

Chongqing University Cancer Hospital is the lead sponsor of 40 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Inpatient at the oncology hospital

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

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 design

Observational model: Case-only
Time perspective: Retrospective
Enrollment: 151 participants (actual)
Patient registry: No

Groups and cohorts

Group A
Those who used TDF
Drug: transdermal fentanyl

Interventions

Drugtransdermal fentanyl
Adult cancer pain patients switched from oral opioid to TDF

What researchers measure

Primary outcomes

11-point numeric rating scale (NRS) after TDF treatment
Ineffectiveness defined as pain with a NRS of 4 or higher.
Time frame: 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
Time frame: in 1 week
The dose adjustment of TDF
Ineffectiveness defined as the dosage of TDF increased
Time frame: in 1 week
The kinds of other analgesics combined with TDF
Ineffectiveness defined as more than one kind of analgesics were combined with TDF
Time frame: in 1 week

Secondary outcomes

Adverse effects
Nausea, vomiting, dizziness, rash, constipation, urinary retention, respiratory depression
Time frame: in 1 week

Study locations

1 site

Chao Li
Chongqing, 400030, China

References and documents

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. PubMed 31076899 ↗
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. PubMed 24469018 ↗
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. PubMed 31568684 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06369961
Lead sponsor: Chongqing University Cancer Hospital
Responsible party: Sponsor
First posted: Apr 17, 2024
Start date: Mar 1, 2023
Primary completion: Jul 31, 2023
Completion: Dec 31, 2023
Last update: Apr 17, 2024

Study contacts

Chao Li

principal investigator · Chongqing University Cancer Hospital

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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