Status:
TERMINATED
Treatment of Breakthrough Cancer Pain According to European Guidelines
Lead Sponsor:
Aziende Chimiche Riunite Angelini Francesco S.p.A
Conditions:
Breakthrough Cancer Pain
Eligibility:
All Genders
18+ years
Brief Summary
Pain is a frequent symptom in cancer patients with a negative impact on the quality of life (QoL).Breakthrough cancer pain (BTcP) is defined as "a transient exacerbation of pain, manifesting spontaneo...
Detailed Description
Typical BTcP episodes are of short duration (15-30 minutes/episode), moderate to severe intensity and rapid onset (maximum peak between 3-15 minutes). The best management of BTcP requires a thorough e...
Eligibility Criteria
Inclusion
- Male and female patients of any ethnic origin of ≥ 18 years.
- Patients diagnosed with locally advanced or recurrent metastatic cancer (histologic or cytologic diagnosis), with BTcP, as assessed by the Investigator.
- Opioid-tolerant patients receiving doses of oral morphine equivalent daily doses (OMEDD) of at least 60 mg.
- Drugs for BTcP treatment, if any, must be used according to the relevant SmPC.
- Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1, or 2.
- Patients with life expectancy \> 3 months.
- Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent.
Exclusion
- Patients with previous or current history of a clinically significant neurological/psychiatric disorder and/or any substance abuse or dependence that, according to the Investigator's judgement, can impair the study end-points/results.
- Patients who have been taking antidepressants and/or drugs acting on pain and who take them on a regular basis during the observation period, can be enrolled.
- Any medical condition or situation complicating the collection of study data, as determined by the Investigator.
Key Trial Info
Start Date :
August 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT04468490
Start Date
August 11 2020
End Date
September 30 2021
Last Update
October 27 2021
Active Locations (1)
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1
Nzoz Zespół Medyczno Opiekuńczy Alicja Kluczna
Dąbrowa Górnicza, Poland, 41-300