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

NCT06369961 | Completed FDA Drug

• 1 other identifier: TDFCANCERPAIN20230101
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Pain; Nutrition Disorders

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Adverse effects

  in 1 week

Study Arms (1)

Group A

Those who used TDF

Drug: transdermal fentanyl

Interventions

transdermal fentanyl DRUG

Adult cancer pain patients switched from oral opioid to TDF

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inpatient at the oncology hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chao Li

Chongqing, 400030, China

Location

Related Publications (4)

• 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.

  PMID: 31076899 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.

  PMID: 24469018 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.

  PMID: 31568684 RESULT

• 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.

  PMID: 40214947 DERIVED

MeSH Terms

Conditions

Cancer Pain; Nutrition Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases

Study Officials

• Chao Li

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 17, 2024
• Study Start: March 1, 2023
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)