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

University Medicine Greifswald72 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pancreatic Carcinoma

Interventions

L-CarnitineDIETARY_SUPPLEMENT

L-Carnitine, 4g/day, orally (Juice)

PlaceboDIETARY_SUPPLEMENT

tartaric acid same dose like L-Carnitine as placebo

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

University Medicine Greifswald,Department of Medicine A

Greifswald, Germany

Outcomes

Primary Outcomes

TNF-alpha

Influence of L-Carnitine on proinflammatory cytokine TNF-alpha

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 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).

Time frame: 12 weeks

survival

Survival time in days was calculated from time of diagnosis until death.

Time frame: 1 year

hospital stay

time of hospital stay

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.