search
Back to results

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

Primary Purpose

Pancreatic Carcinoma

Status
Suspended
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
L-Carnitine
Placebo
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Carcinoma focused on measuring pancreatic carcinoma, L-Carnitine, quality of life, survival, malnutrition, cancer cachexia, fatigue

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medicine Greifswald,Department of Medicine A

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

L-Carnitine

Placebo

Arm Description

L-Carnitine 4 g daily for Intervention

Placebo (tartaric acid)

Outcomes

Primary Outcome Measures

TNF-alpha
Influence of L-Carnitine on proinflammatory cytokine TNF-alpha

Secondary Outcome Measures

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.
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).
survival
Survival time in days was calculated from time of diagnosis until death.
hospital stay
time of hospital stay

Full Information

First Posted
April 5, 2011
Last Updated
April 6, 2011
Sponsor
University Medicine Greifswald
search

1. Study Identification

Unique Protocol Identification Number
NCT01330823
Brief Title
L-CARnitine in the Palliative Treatment of Advanced PANcreatic Cancer (CARPAN)
Acronym
CARPAN
Official Title
L-Carnitine in the Palliative Treatment of Advanced Pancreatic Cancer (CARPAN): a Prospective, Randomised, Placebo Controlled, Double Blinded, Multicentre Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Suspended
Why Stopped
after interims analysis standard errors for inflammatory and nutritional markers varied widely, that the power calculation required unattainable goals
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
July 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Medicine Greifswald

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Carcinoma
Keywords
pancreatic carcinoma, L-Carnitine, quality of life, survival, malnutrition, cancer cachexia, fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L-Carnitine
Arm Type
Active Comparator
Arm Description
L-Carnitine 4 g daily for Intervention
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (tartaric acid)
Intervention Type
Dietary Supplement
Intervention Name(s)
L-Carnitine
Intervention Description
L-Carnitine, 4g/day, orally (Juice)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
tartaric acid same dose like L-Carnitine as placebo
Primary Outcome Measure Information:
Title
TNF-alpha
Description
Influence of L-Carnitine on proinflammatory cytokine TNF-alpha
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
nutritional status
Description
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
Title
Quality of life
Description
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
Title
survival
Description
Survival time in days was calculated from time of diagnosis until death.
Time Frame
1 year
Title
hospital stay
Description
time of hospital stay
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus M. Lerch, Prof.
Organizational Affiliation
University Medicine Greifswald
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medicine Greifswald,Department of Medicine A
City
Greifswald
ZIP/Postal Code
17489
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.pancreas.de
Description
Related Info
URL
http://www.medizin.uni-greifswald.de/
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs