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

NCT ID: NCT01330823

Last Updated: 2011-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-07-31

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

Conditions

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Pancreatic Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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L-Carnitine

L-Carnitine 4 g daily for Intervention

Group Type ACTIVE_COMPARATOR

L-Carnitine

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Placebo (tartaric acid)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

tartaric acid same dose like L-Carnitine as placebo

Interventions

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L-Carnitine

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

tartaric acid same dose like L-Carnitine as placebo

Intervention Type DIETARY_SUPPLEMENT

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Department of Medicine A

Principal Investigators

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Markus M. Lerch, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Locations

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University Medicine Greifswald,Department of Medicine A

Greifswald, , Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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CARPAN-01

Identifier Type: -

Identifier Source: org_study_id

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