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:
University Medicine Greifswald
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT01330823
First received: April 5, 2011
Last updated: April 6, 2011
Last verified: April 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 22, 2013