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

What Was Tested

In this phase 3 trial, researchers set out to test L-Carnitine.

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 .

It had two arms (groups): L-Carnitine (active comparator) and Placebo (placebo comparator).

Placebo (tartaric acid).

The registry classes the interventions as dietary supplement.

Who Took Part

The registry lists 72 actual participants took part.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Advanced pancreatic cancer (UICC Stage IV). Karnofsky Index larger than 60. Consent to participate to the study.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: child-pugh classification of liver failure greater than child b,; a known second malignant tumor; oral or parenteral supplementation with omega-3-fatty acids.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2006-06 with completion listed for 2009-10.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: TNF-alpha (time frame: 12 weeks).

It also tracked 4 secondary outcomes, for example nutritional status, Quality of life, survival and hospital stay.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 72 people.

Its status is suspended; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.