Symptoms and General Pathology

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Nervous System Diseases

Rare Diseases

Cancer Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Adjuvants, Anesthesia

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Fentanyl

Analgesics, Opioid

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Anesthetics, Intravenous

Anesthetics, General

fentanyl

Janssen-Cilag S.A.S. Clinical Trial

The purpose of this study is to determine the safety and efficacy of pain control by fentanyl, administered via adhesive skin patches, at doses of 25 to 100 micrograms per hour in 80 out-patients with intense chronic cancer pain. Higher doses are allowed by permission of the investigator and rescue oral morphine medication is allowed.

Patients with cancer pain are frequently under-medicated with morphine. This is a 56-day open-label study of the efficacy and safety of self-administered fentanyl skin patches for cancer pain control in patients in the home-care setting not previously using morphine. The first 15 days of the study are for dose stabilization and the rest of the study assesses pain control and quality of life at stable doses of medication. The dose is determined by the patient with oversight by the investigator, and rescue oral morphine medication can be used when necessary. The patient records all medication use in a diary and fills out questionnaires concerning pain control, intestinal function (constipation) and overall quality of life. The hypothesis is that patients will be able to control their cancer pain by self-administering transdermal fentanyl at home and that they will well tolerate the medication.

Individualized doses, with a target dose of 25 to 100 micrograms per hour of fentanyl for 56 days via skin patches applied every 3 days to deliver 25 to 100 micrograms of fentanyl per hour per patch; oral morphine as rescue medication for pain.

Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain

Evaluation of the Efficacy and Safety of Transdermal Fentanyl in Patients Suffering From Chronic Cancer Pain in an Ambulatory Setting

Janssen Cilag S.A.S.

Nutritional and Metabolic Diseases

Nutrition Disorders

Adult cancer pain patients switched from oral opioid to TDF

transdermal fentanyl

Chao Li

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.

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

Ineffectiveness defined as pain with a NRS of 4 or higher.

Ineffectiveness defined as the breakthrough pain attacks more than 3 occasions per day

Ineffectiveness defined as the dosage of TDF increased

Ineffectiveness defined as more than one kind of analgesics were combined with TDF

Nausea, vomiting, dizziness, rash, constipation, urinary retention, respiratory depression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain	NCT00236327	Pain	fentanyl	18 Years -	Janssen Cilag S.A.S.
Correlation Between the Analgesic Effect of Fentanyl Transdermal Patches and Nutritional Status in Cancer Pain Patients	NCT06369961	Cancer Pain Nutrition Disor...	transdermal fen...	18 Years -	Chongqing University Cancer Hospital
Correlation Between the Analgesic Effect of Fentanyl Transdermal Patches and Nutritional Status in Cancer Pain Patients	NCT06369961	Cancer Pain Nutrition Disor...	transdermal fen...	18 Years -	Chongqing University Cancer Hospital

Spots Global Cancer Trial Database for transdermal fentanyl