L-CARnitine in the Palliative Treatment of Advanced PANcreatic Cancer (CARPAN)

Study Overview
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Brief Summary
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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 .

Detailed Description
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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

Official Title
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L-Carnitine in the Palliative Treatment of Advanced Pancreatic Cancer (CARPAN): a Prospective, Randomised, Placebo Controlled, Double Blinded, Multicentre Trial

Conditions
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Pancreatic Carcinoma

Intervention / Treatment
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* Dietary Supplement: L-Carnitine
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L-Carnitine<br>L-Carnitine 4 g daily for Intervention | Dietary Supplement: L-Carnitine<br>* L-Carnitine, 4g/day, orally (Juice)<br>|
| Placebo Comparator: Placebo<br>Placebo (tartaric acid) | Dietary Supplement: Placebo<br>* tartaric acid same dose like L-Carnitine as placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF-alpha | Influence of L-Carnitine on proinflammatory cytokine TNF-alpha | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic carcinoma, L-Carnitine, quality of life, survival, malnutrition, cancer cachexia, fatigue