L-Carnitine in the Palliative Treatment of Advanced Pancreatic Cancer (CARPAN): a Prospective, Randomised, Placebo Controlled, Double Blinded, Multicentre Trial
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N/A
Both
Pancreatic Carcinoma
Trial Information
L-Carnitine in the Palliative Treatment of Advanced Pancreatic Cancer (CARPAN): a Prospective, Randomised, Placebo Controlled, Double Blinded, Multicentre Trial
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
TNF-alpha
Outcome Description:
Influence of L-Carnitine on proinflammatory cytokine TNF-alpha
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Markus M. Lerch, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Medicine Greifswald
Authority:
Germany:Ethics Commission for the Medical Faculty of the University of Greifswald
Study ID:
CARPAN-01
NCT ID:
NCT01330823
Start Date:
June 2006
Completion Date:
July 2010
Related Keywords:
- Pancreatic Carcinoma
- pancreatic carcinoma
- L-Carnitine
- quality of life
- survival
- malnutrition
- cancer cachexia
- fatigue
- Carcinoma
- Pancreatic Neoplasms
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