Cancer Clinical Trial
Official title:
A Randomised Controlled Trial in the Palliative Setting Regarding Off-Label Medication: Investigating the Efficiency of Amitriptyline Versus Pregabalin From a Societal Perspective
Rationale: Often, incurable cancer patients suffer from severe symptoms as (neuropathic)
pain and fatigue with polypharmaceutic interventions as a consequence. Regarding neuropathic
pain in incurable cancer patients, pregabalin has been registered for neuropathic non-cancer
pain, and amitriptyline is not registered for neuropathic pain, but is recommended as the
drug of first choice in the Dutch handbooks of palliative care. As a consequence of an
adaptation of a Dutch law (July 2007) about off-label medication prescription, off-label
medication is not allowed anymore unless a standard or protocol exists. No clinical trials
for this patient group have been published before.
Objective: To compare efficacy, side effects and costs of a strategy with amitriptyline as
drug of first choice versus a strategy with pregabalin as drug of first choice.
Study design: An open label, randomised non-inferiority trial Study population: Incurable
cancer patients with neuropathic pain Intervention: When a patient decides to take part in
the study, he will be allocated randomly to one of the two study groups. A minimisation
algorithm will be used, that balances for the cause of neuropathic pain (tumour related
versus treatment related), type of treatment (ongoing chemo- or radiotherapy versus not
ongoing chemo- or radiotherapy) and institution. Each drug will be prescribed in a step up
procedure. Patients will be followed during 8 weeks.
Main study parameters/endpoints: Neuropathic pain, as measured with the mean VAS and McGill
questionnaire, strategy success, costs per strategy, side effects, quality of life and
concomitant analgesic drugs.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: There are hardly any risks for the patients. The drugs in both arms already are
usual care for the target population. If there is no or a too small effect, the drug of the
other arm will be added, which strategy also is already usual care. All other medication,
except for Tricyclic Antidepressants Drugs (TADs) and Anti Epileptic Drugs (AEDs), as well
as radiotherapy and chemotherapy are allowed. The patient has to visit the hospital 2 times
during the study period. The patient had to fill in a pain diary daily (5 min), cost diary
and EQ-5D every other week (10 min), related questionnaires as HADS, McGill and
EORTC-QLQ-C30 monthly (20 min).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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