NCT00034450

Brief Summary

L-carnitine is a supplement (type of vitamin) that has been suggested to be decreased in patients with cancer. We will identify patients that have terminal cancer and fatigue. The purpose of this study is to determine if L-carnitine replacement improves fatigue in cancer patients with L-carnitine deficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2002

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2002

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

August 18, 2006

Status Verified

March 1, 2006

First QC Date

April 29, 2002

Last Update Submit

August 17, 2006

Conditions

Neoplasms

Keywords

Terminal Cancer

Interventions

L-carnitineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diagnosis of cancer and estimated life expectancy of less than 6 months.
  • Patients who have undergone antineoplastic therapy which may worsen fatigue or promote carnitine deficiency will be eligible if completed the therapy more than 90 days prior to beginning the study.

You may not qualify if:

  • Uncontrolled or severe cardiovascular, pulmonary, or renal disease.
  • Patients with encephalopathy or psychiatric disorder sufficiently severe to impair completion of the questionnaire.
  • Treatment or replacement therapy with any form of carnitine less than 12 months prior to enrollment.
  • Known sensitivity to carnitine.
  • History of seizures or stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Carnitine

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Ricardo A. Cruciani, MD, PhD

    Beth Israel Medical Center, Department of Pain Medicine and Palliative Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

April 29, 2002

First Posted

April 30, 2002

Study Start

January 1, 2002

Study Completion

August 1, 2004

Last Updated

August 18, 2006

Record last verified: 2006-03

Locations

US(1)