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

This study has suspended participant recruitment.
(after interims analysis standard errors for inflammatory and nutritional markers varied widely, that the power calculation required unattainable goals)
Sponsor:
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT01330823
First received: April 5, 2011
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

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 .


Condition Intervention Phase
Pancreatic Carcinoma
Dietary Supplement: L-Carnitine
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: L-Carnitine in the Palliative Treatment of Advanced Pancreatic Cancer (CARPAN): a Prospective, Randomised, Placebo Controlled, Double Blinded, Multicentre Trial

Resource links provided by NLM:


Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • TNF-alpha [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Influence of L-Carnitine on proinflammatory cytokine TNF-alpha


Secondary Outcome Measures:
  • nutritional status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Survival time in days was calculated from time of diagnosis until death.

  • hospital stay [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    time of hospital stay


Enrollment: 72
Study Start Date: June 2006
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L-Carnitine
L-Carnitine 4 g daily for Intervention
Dietary Supplement: L-Carnitine
L-Carnitine, 4g/day, orally (Juice)
Placebo Comparator: Placebo
Placebo (tartaric acid)
Dietary Supplement: Placebo
tartaric acid same dose like L-Carnitine as placebo

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330823

Locations
Germany
University Medicine Greifswald,Department of Medicine A
Greifswald, Germany, 17489
Sponsors and Collaborators
University Medicine Greifswald
Investigators
Principal Investigator: Markus M. Lerch, Prof. University Medicine Greifswald
  More Information

Additional Information:
No publications provided

Responsible Party: Markus M Lerch, Professor of Medicine, Department of Medicine A
ClinicalTrials.gov Identifier: NCT01330823     History of Changes
Other Study ID Numbers: CARPAN-01
Study First Received: April 5, 2011
Last Updated: April 6, 2011
Health Authority: Germany:Ethics Commission for the Medical Faculty of the University of Greifswald

Keywords provided by University Medicine Greifswald:
pancreatic carcinoma
L-Carnitine
quality of life
survival
malnutrition
cancer cachexia
fatigue

Additional relevant MeSH terms:
Carcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014