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

Phase 4

Terminated

• Conditions: Pancreatic Cancer; Visceral Pain
• Interventions: Drug: Placebo; Drug: Pregabalin

• Registration Number: NCT01768988
• Lead Sponsor: Parc de Salut Mar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-16
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	Placebo	Conventional analgesic treatment + placebo.
Group I	Pregabalin	Conventional analgesic treatment + pregabalin.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
Neuropathic Pain	From baseline to day 90.	Neuropathic pain participation will be measured by a neuropathic pain questionnaire (NPSI).
Anxiety and depression	From baseline to day 90.	Anxiety and depression will be also assessed, using Hospital Anxiety and Depression Scale (HADS).

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain