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

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ClinicalTrials.gov Identifier: NCT01330823
Recruitment Status : Suspended (after interims analysis standard errors for inflammatory and nutritional markers varied widely, that the power calculation required unattainable goals)
First Posted : April 7, 2011
Last Update Posted : April 7, 2011
Information provided by:
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 .

Condition or disease Intervention/treatment Phase
Pancreatic Carcinoma Dietary Supplement: L-Carnitine Dietary Supplement: Placebo Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : June 2006
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. TNF-alpha [ Time Frame: 12 weeks ]
    Influence of L-Carnitine on proinflammatory cytokine TNF-alpha

Secondary Outcome Measures :
  1. nutritional status [ Time Frame: 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.

  2. Quality of life [ Time Frame: 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).

  3. survival [ Time Frame: 1 year ]
    Survival time in days was calculated from time of diagnosis until death.

  4. hospital stay [ Time Frame: 1 year ]
    time of hospital stay

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330823

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

Additional Information:
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
First Posted: April 7, 2011    Key Record Dates
Last Update Posted: April 7, 2011
Last Verified: April 2011

Keywords provided by University Medicine Greifswald:
pancreatic carcinoma
quality of life
cancer cachexia

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases