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

Pancreatic Cancer Clinical Trial

— PANPAIN/1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01768988
• Other study ID #: PANPAIN/1
• Status: Terminated
• Phase: Phase 4
• First received: January 14, 2013
• Last updated: October 4, 2017
• Start date: August 2012
• Est. completion date: December 2017

Study information

• Verified date: October 2017
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Visceral Pain

Intervention

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).
• 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).

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Performance status	Performance status (Karnofsky Performance Status Scale).	From baseline until to day 90.
Secondary	Anxiety and depression	Anxiety and depression will be also assessed, using Hospital Anxiety and Depression Scale (HADS).	From baseline to day 90.
Secondary	Neuropathic Pain	Neuropathic pain participation will be measured by a neuropathic pain questionnaire (NPSI).	From baseline to day 90.