Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study

Conditions
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Pancreatic Cancer, Visceral Pain

Intervention / Treatment
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* Drug: Placebo
* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>Conventional analgesic treatment + pregabalin. | Drug: Pregabalin<br>* 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: Paracetamol 1g/8h Weak opioid (tramadol at maximal doses of 400 mg/24h) 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).<br>|
| Placebo Comparator: Group II<br>Conventional analgesic treatment + placebo. | Drug: Placebo<br>* Conventional treatment + placebo (during 90 days). Conventional treatment comprises a WHO step ladder approach and comprises in most cases: Paracetamol 1g/8h Weak opioid (tramadol at maximal doses of 400 mg/24h) 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline to day 90. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Changes in quality of life compared to baseline level using SF-36 (Short-Form Health Survey) quality of life questionnaire. | From baseline to day 90. | 
| Performance status | Performance status (Karnofsky Performance Status Scale). | From baseline until to day 90. | 
| Anxiety and depression | Anxiety and depression will be also assessed, using Hospital Anxiety and Depression Scale (HADS). | From baseline to day 90. | 
| Neuropathic Pain | Neuropathic pain participation will be measured by a neuropathic pain questionnaire (NPSI). | From baseline to day 90. |