Conversion From Fast Acting Oral Opioids to Abstral®
The purpose of this study is to evaluate safety and efficacy when using a novel dose conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain|
- Response rate in patients converted to SL fentanyl. [ Time Frame: 30 minutes post dose ] [ Designated as safety issue: No ]A subject is defined as responder if the change of Pain Intensity (PI) on the Numerical Rating Scale (NRS) rated from 0 to 10, at 30 minutes (PID30) is similar or higher after the conversion to SL fentanyl compared to baseline PID30 as assessed by standard care rescue treatment of BTcP episodes.
- Responder rate in patients converted to SL fentanyl as assessed by the PID15. [ Time Frame: 15 minutes post dose ] [ Designated as safety issue: No ]
- Edmonton Symptom Assessment System (ESAS) Symptom Distress Score (SDS) [ Time Frame: 24 hour assessment on days with pain episodes ] [ Designated as safety issue: No ]
- Patient's global assessment of treatment (patient satisfaction). [ Time Frame: 2 occasions ] [ Designated as safety issue: No ]
- Patients preference of treatment (baseline treatment/SL fentanyl). [ Time Frame: end of study ] [ Designated as safety issue: No ]
- Occurrence of AEs, withdrawals [ Time Frame: during a maximum treatment period of 21 days. ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Experimental: Treatment arm||
Drug: SL fentanyl
SL fentanyl will be administered during 7- 15 BTcP episodes during a maximum period of 21 days, following a baseline period with standard BTcP treatment. The start dose of SL fentanyl is selected individually according to a standardized conversion ratio. The maximum start dose is limited to 400 μg. For a single BTcP episode no more than two (2) tablets or a maximum dose of 800 μg should be given.
Other Name: Abstral
The study aims to show that in the advanced stage of cancer the individual patient already on high doses of BTcP medication will benefit from starting treatment on a higher first dose of SL fentanyl thus reducing the number of dosing steps with insufficient pain relief.