Cancer PainNCT06369961
Correlation Between the Analgesic Effect of Fentanyl Transdermal Patches and Nutritional Status in Cancer Pain Patients
An observational study of Cancer Pain and Nutrition Disorders, run by Chongqing University Cancer Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Nutrition Disorders
- What is being tested?
- transdermal fentanyl
- Type of treatment
- Pill or oral medicine
- How many people
- 151 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatient at the oncology hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Clinical Study on the Impact of Nutritional Status on the Analgesic Effect of Fentanyl Transdermal Patches in Cancer Pain Patients
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
- Cancer Pain, Nutrition Disorders
- Being tested
- transdermal fentanyl
- Medical subject headings
- Cancer Pain, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transdermal fentanylDrug
Adult cancer pain patients switched from oral opioid to TDF
| Study group | Role | What they receive |
|---|---|---|
| Group A | Those who used TDF Receives: Drug: transdermal fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
11-point numeric rating scale (NRS) after TDF treatment
Ineffectiveness defined as pain with a NRS of 4 or higher.
Measured: 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
Measured: in 1 week
The dose adjustment of TDF
Ineffectiveness defined as the dosage of TDF increased
Measured: in 1 week
The kinds of other analgesics combined with TDF
Ineffectiveness defined as more than one kind of analgesics were combined with TDF
Measured: in 1 week
Secondary outcomes (1)
Adverse effects
Nausea, vomiting, dizziness, rash, constipation, urinary retention, respiratory depression
Measured: in 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Mar 2023
- Primary completion31 Jul 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao Li, Principal investigator, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369961
- Sponsor's protocol ID
- TDFCANCERPAIN20230101
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 31076899Barratt 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 24469018Moryl 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 31568684Chen 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.
PubMed 40214947
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Clinical Study on the Impact of Nutritional Status on the Analgesic Effect of Fentanyl Transdermal Patches in Cancer Pain Patients
- ClinicalTrials.gov ID
- NCT06369961
- Acronym / sponsor ID
- TDFCANCERPAIN20230101
- Conditions
- Cancer Pain, Nutrition Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: transdermal fentanylThose who used TDF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient at the oncology hospital
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transdermal fentanylAdult cancer pain patients switched from oral opioid to TDF | Drug | Group A |
Primary outcome
11-point numeric rating scale (NRS) after TDF treatment
Time frame: in 1 week
Ineffectiveness defined as pain with a NRS of 4 or higher.
the occasions that breakthrough pain attacks per day after TDF treatment
Time frame: in 1 week
Ineffectiveness defined as the breakthrough pain attacks more than 3 occasions per day
The dose adjustment of TDF
Time frame: in 1 week
Ineffectiveness defined as the dosage of TDF increased
The kinds of other analgesics combined with TDF
Time frame: in 1 week
Ineffectiveness defined as more than one kind of analgesics were combined with TDF
1 secondary outcome
Adverse effects
Time frame: in 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Results publication: PubMed 31076899Minello 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.
- Results publication: PubMed 24469018Barratt 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.
- Results publication: PubMed 31568684Moryl 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.
- Derived from this study: PubMed 40214947Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao Li principal investigator
Chongqing University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Pain and Nutrition Disorders, run by Chongqing University Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
11-point numeric rating scale (NRS) after TDF treatment (time frame: in 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06369961, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.