This is a randomized, double blind controlled, parallel arms trial, aimed to assess the efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing the presence of central sensitization and its potential reversion by Pregabalin; (3) assessing quality of life of patients treated with pregabalin in comparison to placebo; (4) to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5) to compare anxiety and depression in patients treated with pregabalin in comparison to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Conventional treatment + placebo (during 90 days). Conventional treatment comprises a WHO step ladder approach and comprises in most cases: 1. Paracetamol 1g/8h 2. Weak opioid (tramadol at maximal doses of 400 mg/24h) 3. Strong opioid in substitution of weak opioid if not efficient (e. g. morphine, oxycodone, fentanyl patch, hidromorphone), at the needed doses to control pain (VAS \< 3).
Treatment during 90 days with conventional treatment + pregabalin. Pregabalin doses were reached until the maximal doses (300 mg/12h) depending on patient tolerability. An escalating dose scheme were desigened as follows, to avoid tolerability problems: Week 1 75-0-75 Week 2 75-0-150 Week 3 150-0-150 Week 4 150-0-300 Week 5 300-0-300 (until the end of study) Conventional treatment comprises a WHO step ladder approach and comprises in most cases: 1. Paracetamol 1g/8h 2. Weak opioid (tramadol at maximal doses of 400 mg/24h) 3. Strong opioid in substitution of weak opioid if not efficient (e. g. morphine, oxycodone, fentanyl patch, hidromorphone), at the needed doses to control pain (VAS \< 3).
Hospital del Mar
Barcelona, Spain
Pain intensity (Visual Analogue Scale; VAS Score)
Analgesic effect of pregabalin therapy in pancreatic cancer patients, assessed using a visual analogue scale (VAS), the Brief Pain Inventory (BPI) and Neuropathic Pain VAS score.
Time frame: From baseline to day 90.
Quality of life
Changes in quality of life compared to baseline level using SF-36 (Short-Form Health Survey) quality of life questionnaire.
Time frame: From baseline to day 90.
Performance status
Performance status (Karnofsky Performance Status Scale).
Time frame: From baseline until to day 90.
Anxiety and depression
Anxiety and depression will be also assessed, using Hospital Anxiety and Depression Scale (HADS).
Time frame: From baseline to day 90.
Neuropathic Pain
Neuropathic pain participation will be measured by a neuropathic pain questionnaire (NPSI).
Time frame: From baseline to day 90.
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