Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study (PANPAIN/1)

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 Overview

• Status: Terminated
• Conditions: Pancreatic Cancer; Visceral Pain
• Intervention / Treatment: Drug: Pregabalin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Conventional analgesic treatment + pregabalin.	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: 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).
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: 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).

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: January 14, 2013
• First Submitted That Met QC Criteria: January 15, 2013
• First Posted (Estimate): January 16, 2013

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Nociceptive Pain; Pancreatic Neoplasms; Cancer Pain; Visceral Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: PANPAIN/1