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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
Sponsor:
Information provided by:
University Medicine Greifswald

April 5, 2011
April 7, 2011
April 7, 2011
June 2006
October 2009   (Final data collection date for primary outcome measure)
TNF-alpha [ Time Frame: 12 weeks ]
Influence of L-Carnitine on proinflammatory cytokine TNF-alpha
Same as current
No Changes Posted
  • 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.
  • 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).
  • survival [ Time Frame: 1 year ]
    Survival time in days was calculated from time of diagnosis until death.
  • hospital stay [ Time Frame: 1 year ]
    time of hospital stay
Same as current
Not Provided
Not Provided
 
L-CARnitine in the Palliative Treatment of Advanced PANcreatic Cancer (CARPAN)
L-Carnitine in the Palliative Treatment of Advanced Pancreatic Cancer (CARPAN): a Prospective, Randomised, Placebo Controlled, Double Blinded, Multicentre Trial
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 .

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

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Pancreatic Carcinoma
  • Dietary Supplement: L-Carnitine
    L-Carnitine, 4g/day, orally (Juice)
  • Dietary Supplement: Placebo
    tartaric acid same dose like L-Carnitine as placebo
  • Active Comparator: L-Carnitine
    L-Carnitine 4 g daily for Intervention
    Intervention: Dietary Supplement: L-Carnitine
  • Placebo Comparator: Placebo
    Placebo (tartaric acid)
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
72
Same as current
July 2010
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01330823
CARPAN-01
Yes
Not Provided
Not Provided
Markus M Lerch, Professor of Medicine, Department of Medicine A
University Medicine Greifswald
Not Provided
Principal Investigator: Markus M. Lerch, Prof. University Medicine Greifswald
University Medicine Greifswald
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP