Pancreatic Cancer, Visceral Pain
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
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).
DRUGPregabalin
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).
Sponsors
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Patients \> 18 years old recently diagnosed of pancreatic cancer (\<3 months). * 2\. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial. * 3\. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
Exclusion criteria
* 1\. Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator. * 2\. Patients with previously diagnosed moderate to severe renal impairment. Those with a Clearance of Creatinine (CLcr) \< 60mL/min should be excluded. * 3\. Patients treated with anticonvulsants during the previous 4 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (Visual Analogue Scale; VAS Score) | From baseline to day 90. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | From baseline to day 90. | Changes in quality of life compared to baseline level using SF-36 (Short-Form Health Survey) quality of life questionnaire. |
| Performance status | From baseline until to day 90. | Performance status (Karnofsky Performance Status Scale). |
| Anxiety and depression | From baseline to day 90. | Anxiety and depression will be also assessed, using Hospital Anxiety and Depression Scale (HADS). |
| Neuropathic Pain | From baseline to day 90. | Neuropathic pain participation will be measured by a neuropathic pain questionnaire (NPSI). |
Countries
Spain
Outcome results
None listed