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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Those who used TDF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transdermal fentanyl | Drug | Adult cancer pain patients switched from oral opioid to TDF |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | Nausea, vomiting, dizziness, rash, constipation, urinary retention, respiratory depression | in 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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Inpatient at the oncology hospital
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| Name | Affiliation | Role |
|---|---|---|
| Chao Li | Chongqing University Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Li | Chongqing | 400030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31076899 | Result | 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. | |
| 24469018 | Result | 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. |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D009748 | Nutrition Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 31568684 | Result | 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. |
| 40214947 | Derived | 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. |
| D009750 | Nutritional and Metabolic Diseases |