Pancreatic Carcinoma
Conditions
Keywords
pancreatic carcinoma, L-Carnitine, quality of life, survival, malnutrition, cancer cachexia, fatigue
Brief summary
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
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
Interventions
DIETARY_SUPPLEMENTL-Carnitine
L-Carnitine, 4g/day, orally (Juice)
DIETARY_SUPPLEMENTPlacebo
tartaric acid same dose like L-Carnitine as placebo
Sponsors
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TNF-alpha | 12 weeks | Influence of L-Carnitine on proinflammatory cytokine TNF-alpha |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| nutritional status | 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 | 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 | 1 year | Survival time in days was calculated from time of diagnosis until death. |
| hospital stay | 1 year | time of hospital stay |
Countries
Germany
Outcome results
None listed