RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder. — CERP

Cancer Clinical Trial

Official title:
RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder.

Status Completed

Clinical Trial Summary

Pain, in neoplastic disease, is a symptom with severe negative impact on the quality of life of patients and a high incidence, with values around 70-90% in advanced and metastatic stages. Than 20 years the main reference for the pharmacological treatment of cancer pain are the guidelines produced by the World Health Organization (WHO). This document shows that the use of opioid drugs is the mainstay of treatment, with particular reference to opioids "major" (3 rd step of the analgesic ladder). The 4 opioids more most commonly prescribed in Italy (oral morphine and oxycodone, fentanyl and buprenorphine transdermal), based on the data currently available, have an analgesic effect would partly overlap but with different percentages of non-responders (NR), a different need to increase the dose over time to maintain adequate analgesia, a different action to the switch to another molecule for ineffectiveness analgesic. The observations described suggest that opioids, although they belong to the same family drug may not be fully comparable with regard to the clinical effects products. Important differences are known on the pharmacokinetic and pharmacodynamic and, more recently, also in terms of pharmacogenomics. This is a comparative study of analgesic strategies based on the use of the 4 mentioned opioids, going to look for possible differences in terms of analgesic efficacy, changes in dose over time, use of switch or permanent abandonment of treatment, parallel to the contour of the side effects. The associated sub-project will link the structure gene of patients and clinical results have emerged.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01809106
Study type	Interventional
Source	Mario Negri Institute for Pharmacological Research
Contact
Status	Completed
Phase	Phase 4
Start date	April 2011
Completion date	October 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05346796` - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial	N/A
Recruiting	`NCT05094804` - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	Phase 1/Phase 2
Completed	`NCT04867850` - Effect of Behavioral Nudges on Serious Illness Conversation Documentation	N/A
Enrolling by invitation	`NCT04086251` - Remote Electronic Patient Monitoring in Oncology Patients	N/A
Completed	`NCT01285037` - A Study of LY2801653 in Advanced Cancer	Phase 1
Completed	`NCT00680992` - Study of Denosumab in Subjects With Giant Cell Tumor of Bone	Phase 2
Completed	`NCT00062842` - Study of Irinotecan on a Weekly Schedule in Children	Phase 1
Active, not recruiting	`NCT04548063` - Consent Forms in Cancer Research: Examining the Effect of Length on Readability	N/A
Completed	`NCT04337203` - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship	N/A
Recruiting	`NCT04349293` - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways	N/A
Terminated	`NCT02866851` - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy	N/A
Active, not recruiting	`NCT05304988` - Development and Validation of the EFT for Adolescents With Cancer
Completed	`NCT04448041` - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed	`NCT00340522` - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting	`NCT04843891` - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.	Phase 1
Active, not recruiting	`NCT03844048` - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial	Phase 3
Completed	`NCT03109041` - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source	Phase 1
Completed	`NCT03167372` - Pilot Comparison of N-of-1 Trials of Light Therapy	N/A
Terminated	`NCT01441115` - ECI301 and Radiation for Advanced or Metastatic Cancer	Phase 1
Recruiting	`NCT06206785` - Resting Energy Expenditure in Palliative Cancer Patients

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.