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

Study Overview

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.

N/A

Pancreatic Cancer
Visceral Pain

DRUG: Placebo
DRUG: Pregabalin

PANPAIN/1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-01-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-10-04
First Submitted that Met QC Criteria 2013-01-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-10-06
First Posted (ACTUAL) 2013-01-16	Results First Posted N/A	Last Verified 2017-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Group I Conventional analgesic treatment + pregabalin.	DRUG: Placebo 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 DRUG: Pregabalin 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:
PLACEBO_COMPARATOR: Group II Conventional analgesic treatment + placebo.	DRUG: Placebo 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Group I

Conventional analgesic treatment + pregabalin.

DRUG: Placebo

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

DRUG: Pregabalin

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:

PLACEBO_COMPARATOR: Group II

Conventional analgesic treatment + placebo.

DRUG: Placebo

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

Primary Outcome Measures	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	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.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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