NCT01946555

Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The BTP (Breakthrough pain)was defined as "a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain". The BTP is a common clinical features in patients with cancer pain (BTcP: breakthrough cancer pain). The prevalence of BTcP is equal to 56%. Currently, the investigators tend to recognize the idiopathic/spontaneous or accident BTcP in the three sub-types: voluntary, non- voluntary and procedural. The diagnosis of BTCP is not always easy because in the cancer patient is normal to observe changes in the intensity of pain during the day, so it is necessary to differentiate slight fluctuations from the presence of real episodes of BTCP, for which is necessary to use a rescue treatment adjusted. In the study will be proposed the use of a diagnostic algorithm, present in the literature, to perform the diagnosis of BTCP. In the presence of BTCP, is important both a correct controlled background pain with major opioids, which can reduce the number and the intensity of the painful episodes, both implement an adjunctive therapy, called "rescue", to be administered at the time which takes over the painful episode using, in this case, an opioid greater.

Conditions

• Tumor
• Cancer Pain
• Breakthrough Cancer Pain
• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Morphine
DRUG	Fentanyl
DRUG	Methadone
DRUG	Buprenorphine
DRUG	Oxycodone
DRUG	Hydromorphone
DRUG	Tapentadol

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-09-19
• Last updated: 2016-04-14

Locations

11 sites across 1 country: Italy