L-CARnitine in the Palliative Treatment of Advanced PANcreatic Cancer (CARPAN)

Pancreatic Carcinoma Clinical Trial

— CARPAN  

Official title:

L-Carnitine in the Palliative Treatment of Advanced Pancreatic Cancer (CARPAN): a Prospective, Randomised, Placebo Controlled, Double Blinded, Multicentre Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01330823
• Other study ID #: CARPAN-01
• Status: Suspended
• Phase: Phase 3
• First received: April 5, 2011
• Last updated: April 6, 2011
• Start date: June 2006
• Est. completion date: July 2010

Study information

• Verified date: April 2011
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany:Ethics Commission for the Medical Faculty of the University of Greifswald
• Study type: Interventional

Clinical Trial Summary

The study investigated the role of L-Carnitine supplementation on proinflammatory immune response, malnutrition, cancer cachexia and cancer related fatigue in advanced and inoperable pancreatic cancer, UICC Stage IV .

Description:

Pancreatic cancer has the lowest 5-year survival rate of any cancer and ranks as the fourth leading cause of cancer death world wide. Several metabolic changes are present in the whole body in case of cancer so the investigators conducted a placebo controlled, double blinded, randomized, prospective and multicentre study to investigate, whether L-Carnitine supplementation may have an impact on malnutrition, cancer cachexia and cancer related fatigue in advanced pancreatic cancer.

Study drug: L-Carnitine 4g per day (vers) Placebo Study design: A multi-centre, double blind, and placebo-controlled, randomised, parallel group study

Patient population: Patients with advanced pancreatic carcinoma Number of patients: Total of 90 patients in two equal groups number of centres: 4 (Greifswald, Magdeburg, Berlin,Heidelberg,all Germany) Duration of dosing: 12 weeks

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 72
• Est. completion date: July 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• advanced pancreatic cancer (UICC Stage IV)

• Karnofsky Index larger than 60

• compliance

• consent to participate to the study

Exclusion Criteria:

• Child-Pugh classification of liver failure greater than Child B,

• a known second malignant tumor

• oral or parenteral supplementation with omega-3-fatty acids

• treatment with thalidomide or Infliximab

• mental or physical disorders

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Carcinoma
• Pancreatic Neoplasms

Intervention

Dietary Supplement:
• L-Carnitine
L-Carnitine, 4g/day, orally (Juice)
• Placebo
tartaric acid same dose like L-Carnitine as placebo

Locations

Country	Name	City	State
Germany	University Medicine Greifswald,Department of Medicine A	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TNF-alpha	Influence of L-Carnitine on proinflammatory cytokine TNF-alpha	12 weeks	No
Secondary	nutritional status	Bioelectrical impedance analysis (BIA) was performed,BCM / ECM index, phase angle, body fat was measured. Increase of body weight and body mass index and and also weight loss were investigated.	12 weeks	No
Secondary	Quality of life	Quality of life was determined using the European EORTC QLQ-C30 form, along with an additional disease specific pancreatic cancer module PAN26 and also Brief Fatique Inventory (BFI).	12 weeks	No
Secondary	survival	Survival time in days was calculated from time of diagnosis until death.	1 year	No
Secondary	hospital stay	time of hospital stay	1 year	No

External Links

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