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Single arm, non-random, open, prospective study on the efficacy and safety of low-dose fentanyl transdermal patch in opioid-naive patients with moderate to severe cancer pain

Single arm, non-random, open, prospective study on the efficacy and safety of low-dose fentanyl transdermal patch in opioid-naive patients with moderate to severe cancer pain

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-17014080
Enrollment
Unknown
Registered
2017-12-21
Start date
2017-12-25
Completion date
Unknown
Last updated
2019-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer pain

Interventions

Experiment Group:Fentanyl transdermal patch 12.5ug q72h

Sponsors

Xuzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Aged =18 years old; (2) body weight greater than 45Kg; (3) patients with malignant tumors, with clear pathologic evidence; (4) PS 0-3; (5) moderate to severe cancer pain (NRS = 4 points); (6) the expected survival time is greater than 3 months; (7) Non-radiotherapy or pain sites are not irradiated; (8) Opioids are not tolerated; (9) voluntarily join the study and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) the pain of the subject is associated with acute tumor emergency such as intestinal obstruction / perforation, spinal cord compression, epidural metastasis, or weight-bearing bone fractures. (2) In addition to the analgesic drugs, treatment received in the first one month of the group (such as bisphosphonates, chemoradiotherapy, targeted therapy, interventional therapy, etc.) was determined by the researchers to produce a direct pain relief effect; (3) history of drug abuse, history of drug addiction or severe alcoholism; (4) history of psychotropic drug dependence; (5) Opioid allergy; (6) Chronic obstructive or other pulmonary disease; (7) Brain trauma and intracranial hypertension; (8) Heart attack patients with bradycardia; (9) hepatic insufficiency (ALT=2.5×ULNAST=2.5×ULNTBIL=1.5×ULN), renal insufficiency (Cr=2.5×ULN),Except for liver and renal primary tumor; (10) Fever or in vitro heat; (11) Pregnant, lactating women; (12) Transdermal patch release> 48 hours or 24 hours before the next assessment; (13) The researchers found it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Efficacy;safety;Quality of Life;Cognitive function;

Countries

China

Contacts

Public ContactLiu Yong

Xuzhou Central Hospital

lyly.7011@163.com+86 18012018131

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026