Breakthrough Cancer Pain
Conditions
Keywords
Instanyl, non-interventional, breakthrough cancer pain, BTP, BTCP, Intranasal fentanyl spray
Brief summary
The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period.
Interventions
None listed
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult cancer patients suffering from BTP * Instanyl should be prescribed in accordance with the Summary of Product Characteristics (SPC) and none of the stated contradictions applies * The decision to prescribe should be made independently of the study * All patients must provide signed Informed Consent prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success of titration (Y/N), defined as reaching a maintenance dose | At week 4 and month 3 after baseline |
| Dose level of Instanyl® after titration, defined as the maintenance dose | At week 4 and month 3 after baseline |
Secondary
| Measure | Time frame |
|---|---|
| Change in Instanyl® maintenance dose | At week 4 and month 3 after baseline |
| Change in level of background medication (standardised daily dose) | At week 4 and month 3 after baseline |
| Adverse Drug Reactions (ADR) | At week 4 and month 3 after baseline |
| Treatment satisfaction | At baseline and week 4 |
| Pain, pain relief and impact of pain of daily life | At baseline and week 4 |
| Reason and time for Instanyl® termination | At week 4 and month 3 after baseline |
Countries
Denmark, France, Greece, Ireland, Norway, Sweden, United Kingdom
Outcome results
None listed