Condition category
Cancer
Date applied
24/03/2011
Date assigned
12/04/2011
Last edited
17/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Markus Lerch

ORCID ID

Contact details

Department of Medicine A
University Medicine Greifswald
Friedrich Löffler Straße 23a
Greifswald
17475
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

L-Carnitine in the palliative treatment of advanced pancreatic cancer (CARPAN): a prospective, randomised, placebo controlled, double blinded, multicentre trial

Acronym

CARPAN

Study hypothesis

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, International Union Against Cancer Classification (UICC) Stage IV .

Ethics approval

Ethics Commission for the Medical Faculty of the University of Greifswald approved on 30.11.2005, ref no: UV 73/05

Study design

Placebo controlled double blinded randomised prospective multicentre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Advanced pancreatic cancer

Intervention

Intervention (Verum): L-Carnitine 4 g/day
Placebo: Tartaric acid
Both administered orally

The trial duration was 3 month, patient visit at time of enrolment, week 6 and week 12

Intervention type

Drug

Phase

Not Applicable

Drug names

L-Carnitine

Primary outcome measures

Influence of L-Carnitine on proinflammatory cytokine tumor necrosis factor (TNF)-alpha

Secondary outcome measures

1. Influence of L-Carnitine on
1.1. Other proinflammatory cytokines (IL 6, IL8, IL12)
1.2. C-reactive protein (CRP)
1.3. Malnutrition and cancer cachexia, cancer related fatigue syndrome
1.4. Mortality
1.5. Hospital stay

Overall trial start date

01/06/2006

Overall trial end date

31/10/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Advanced pancreatic cancer (UICC Stage IV)
2. A Karnofsky Index larger than 60
3. Compliance
4. The consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90 patients

Participant exclusion criteria

1. Patients were excluded with a Child-Pugh classification of liver failure greater than Class B
2. A known second malignant tumor
3. Oral or parenteral supplementation with omega-3-fatty acids
4. Treatment with Thalidomide or Infliximab
5. Mental or physical disorders

Recruitment start date

01/06/2006

Recruitment end date

31/10/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Medicine A
Greifswald
17475
Germany

Sponsor information

Organisation

University Medicine Greifswald (Germany)

Sponsor details

Department of Medicine A
University Medicine Greifswald
Friedrich Löffler Straße 23a
Greifswald
17475
Germany

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Medicine Greifswald (Germany) - Department of Medicine A

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes