NCT01330823

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 .

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
72

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
Last Updated

April 7, 2011

Status Verified

April 1, 2011

Enrollment Period

3.3 years

First QC Date

April 5, 2011

Last Update Submit

April 6, 2011

Conditions

Pancreatic Carcinoma

Keywords

pancreatic carcinomaL-Carnitinequality of lifesurvivalmalnutritioncancer cachexiafatigue

Outcome Measures

Primary Outcomes (1)

  • TNF-alpha

    Influence of L-Carnitine on proinflammatory cytokine TNF-alpha

    12 weeks

Secondary Outcomes (4)

  • nutritional status

    12 weeks

  • Quality of life

    12 weeks

  • survival

    1 year

  • hospital stay

    1 year

Study Arms (2)

L-Carnitine

ACTIVE COMPARATOR

L-Carnitine 4 g daily for Intervention

Dietary Supplement: L-Carnitine

Placebo

PLACEBO COMPARATOR

Placebo (tartaric acid)

Dietary Supplement: Placebo

Interventions

L-CarnitineDIETARY_SUPPLEMENT

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

L-Carnitine
PlaceboDIETARY_SUPPLEMENT

tartaric acid same dose like L-Carnitine as placebo

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • advanced pancreatic cancer (UICC Stage IV)
  • Karnofsky Index larger than 60
  • compliance
  • consent to participate to the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine Greifswald,Department of Medicine A

Greifswald, 17489, Germany

Location

Related Links

MeSH Terms

Conditions

Pancreatic NeoplasmsMalnutritionFatigue

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Markus M. Lerch, Prof.

    University Medicine Greifswald

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2011

First Posted

April 7, 2011

Study Start

June 1, 2006

Primary Completion

October 1, 2009

Study Completion

July 1, 2010

Last Updated

April 7, 2011

Record last verified: 2011-04

Locations

DE(1)