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

Phase 3

Suspended

• Conditions: Pancreatic Carcinoma
• Interventions: Dietary Supplement: L-Carnitine; Dietary Supplement: Placebo

• Registration Number: NCT01330823
• Lead Sponsor: University Medicine Greifswald

Brief 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 .

Detailed 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

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2009-10
• Study Completion: 2010-07
• Status Verified: 2011-04
• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-06
• Last Update Submitted: 2011-04-06
• Study First Posted: 2011-04-07
• Last Update Posted: 2011-04-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-Carnitine	L-Carnitine	L-Carnitine 4 g daily for Intervention
Placebo	Placebo	Placebo (tartaric acid)

Primary Outcome Measures

Name	Time	Method
TNF-alpha	12 weeks	Influence of L-Carnitine on proinflammatory cytokine TNF-alpha

Secondary Outcome Measures

Name	Time	Method
nutritional status	12 weeks	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.
Quality of life	12 weeks	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).
survival	1 year	Survival time in days was calculated from time of diagnosis until death.
hospital stay	1 year	time of hospital stay

Trial Locations

Locations (1)

University Medicine Greifswald,Department of Medicine A; 🇩🇪 Greifswald, Germany