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

NCT ID: NCT06369961

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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Cancer Pain Nutrition Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A

Those who used TDF

transdermal fentanyl

Intervention Type DRUG

Adult cancer pain patients switched from oral opioid to TDF

Interventions

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transdermal fentanyl

Adult cancer pain patients switched from oral opioid to TDF

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chongqing University Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chao Li

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Cancer Hospital

Locations

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Chao Li

Chongqing, , China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 31076899 (View on PubMed)

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.

Reference Type RESULT
PMID: 24469018 (View on PubMed)

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.

Reference Type RESULT
PMID: 31568684 (View on PubMed)

Chen Y, Han S, Hu X, Ma X, Qiu Y, Tang Y, Wang X, Li L, Li C, Chen W. High BMI predicts poor cancer pain relief when rotating from oral opioids to transdermal Fentanyl: a two-center retrospective study. Pharmacol Rep. 2025 Jun;77(3):789-799. doi: 10.1007/s43440-025-00723-8. Epub 2025 Apr 11.

Reference Type DERIVED
PMID: 40214947 (View on PubMed)

Other Identifiers

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TDFCANCERPAIN20230101

Identifier Type: -

Identifier Source: org_study_id

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