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
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Carcinoma||Dietary Supplement: L-Carnitine Dietary Supplement: Placebo||Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
- TNF-alpha [ Time Frame: 12 weeks ]Influence of L-Carnitine on proinflammatory cytokine TNF-alpha
- 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
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|
|Principal Investigator:||Markus M. Lerch, Prof.||University Medicine Greifswald|