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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06369961
Enrollment
151
Registered
2024-04-17
Start date
2023-03-01
Completion date
2023-12-31
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Pain, Nutrition Disorders

Brief 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.

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.

Interventions

Adult cancer pain patients switched from oral opioid to TDF

Sponsors

Chongqing University Cancer Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
11-point numeric rating scale (NRS) after TDF treatmentin 1 weekIneffectiveness defined as pain with a NRS of 4 or higher.
the occasions that breakthrough pain attacks per day after TDF treatmentin 1 weekIneffectiveness defined as the breakthrough pain attacks more than 3 occasions per day
The dose adjustment of TDFin 1 weekIneffectiveness defined as the dosage of TDF increased
The kinds of other analgesics combined with TDFin 1 weekIneffectiveness defined as more than one kind of analgesics were combined with TDF

Secondary

MeasureTime frameDescription
Adverse effectsin 1 weekNausea, vomiting, dizziness, rash, constipation, urinary retention, respiratory depression

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026