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2006-06
2009-10
2010-07
72
NCT01330823
University Medicine Greifswald
University Medicine Greifswald
INTERVENTIONAL
L-CARnitine in the Palliative Treatment of Advanced PANcreatic Cancer (CARPAN)
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2011-04-05 | N/A | 2011-04-06 |
2011-04-06 | N/A | 2011-04-07 |
2011-04-07 | N/A | 2011-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: L-Carnitine L-Carnitine 4 g daily for Intervention | DIETARY_SUPPLEMENT: L-Carnitine
|
| PLACEBO_COMPARATOR: Placebo Placebo (tartaric acid) | DIETARY_SUPPLEMENT: Placebo
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| TNF-alpha | Influence of L-Carnitine on proinflammatory cytokine TNF-alpha | 12 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| nutritional status | 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. | 12 weeks |
| Quality of life | 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). | 12 weeks |
| survival | Survival time in days was calculated from time of diagnosis until death. | 1 year |
| hospital stay | time of hospital stay | 1 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
