Cancers, Pain
Conditions
Keywords
Pain, Cancer, Breakthrough
Brief summary
Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting painkiller often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will test the efficacy and safety of Nasalfent compared to Immediate Release Morphine Sulphate in the treatment of breakthrough cancer pain.
Detailed description
Current treatments for breakthrough cancer pain (BTCP)work too slowly to meet the fast onset of most BTCP episodes, they continue to act longer than the episode of pain lasts and so can have unwanted side effects due to this 'over treatment' of the pain episode. In addition many cancer patients have oral problems which make taking pain relief medication by mouth uncomfortable for the patient. Nasalfent is administered via the nose as a simple spray and can be taken by patients or given by their carers. The nasal route is a common way to administer medication for example in the treatment of migraine or allergy. At any time during the study the patient may take their regular treatment for BTCP should they so wish. This study will compare the time of onset and degree of pain relief of Nasalfent to that of Immediate Release Morphine Sulphate. The safety of the two treatment options will also be examined.
Interventions
DRUGFentanyl citrate
nasal spray, 100, 200, 400 or 800 mcg dosage according to need, to treat up to four episodes of BTCP per day
DRUGImmediate release morphine sulphate
drug dose as required by patient taken to treat up to four epsiodes of BTCP per day
Sponsors
Archimedes Development Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able and willing to give consent * Women of childbearing potential must have a) negative urine pregnancy test b) not be breast feeding c) agree to practice a reliable form of contraception * Diagnosis of cancer * Taking at least 60mg oral morphine or equivalent as 24 hour treatment for cancer-related pain * Experiencing on average 1 - 4 episodes of breakthrough cancer pain per day usually controlled by rescue pain medication * Able (or via caregiver) to evaluate and record pain relief, assess medication performance at set times after dosing, record adverse events, record each use of the study drug or rescue medication in a diary * Able to be up and about for 50% of the day or greater
Exclusion criteria
* Intolerance to opioids or fentanyl * rapidly increasing/uncontrolled pain * pain that is not cancer-related
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Relief | Various time points |
Secondary
| Measure | Time frame |
|---|---|
| Pain Relief at various time points | Various time points |
Countries
United Kingdom
Outcome results
None listed