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

Primary Purpose

Pancreatic Cancer, Visceral Pain

Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Placebo
Pregabalin
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital del Mar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group I

Group II

Arm Description

Conventional analgesic treatment + pregabalin.

Conventional analgesic treatment + placebo.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 14, 2013
Last Updated
October 4, 2017
Sponsor
Parc de Salut Mar
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1. Study Identification

Unique Protocol Identification Number
NCT01768988
Brief Title
Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
Acronym
PANPAIN/1
Official Title
Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Change of PI. Former PI changed from Research Center and Promoter obliged unexpectedly to change the PI.
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Visceral Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
Conventional analgesic treatment + pregabalin.
Arm Title
Group II
Arm Type
Placebo Comparator
Arm Description
Conventional analgesic treatment + placebo.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain intensity (Visual Analogue Scale; VAS Score)
Description
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.
Time Frame
From baseline to day 90.
Secondary Outcome Measure Information:
Title
Quality of life
Description
Changes in quality of life compared to baseline level using SF-36 (Short-Form Health Survey) quality of life questionnaire.
Time Frame
From baseline to day 90.
Title
Performance status
Description
Performance status (Karnofsky Performance Status Scale).
Time Frame
From baseline until to day 90.
Title
Anxiety and depression
Description
Anxiety and depression will be also assessed, using Hospital Anxiety and Depression Scale (HADS).
Time Frame
From baseline to day 90.
Title
Neuropathic Pain
Description
Neuropathic pain participation will be measured by a neuropathic pain questionnaire (NPSI).
Time Frame
From baseline to day 90.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain

12. IPD Sharing Statement

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

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