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Chemotherapy Toxicity Reduction Via Urea Cycle Support

2014-08-27 03:48:49 | BioPortfolio

Summary

Patients undergoing bone marrow transplantation (BMT) and peripheral blood stem cell transplants (PBSCT) frequently develop organ dysfunctions, much of which may be initiated by damage to the liver and to cells lining blood vessels.

We, the researchers at Vanderbilt University, propose to perform a randomized, prospective, double-blind, placebo-controlled study of 144 patients undergoing allogeneic marrow transplantation. The treatment is aimed at supporting hepatic urea cycle function in patients receiving escalated dose chemotherapy/BMT. By so doing we hope to prevent development of hepatic venoocclusive disease (HVOD) and acute lung injury (ALI), two morbid complications of BMT. Patients will be randomized to receive oral citrulline, a urea cycle amino acid intermediate, or placebo beginning before conditioning therapy and continuing until 21 days after BMT. All patients will be followed for 100 days after study enrollment with intensive data collection.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Conditions

Cancer

Intervention

Citrulline

Location

Vanderbilt University Medical Center
Nashville
Tennessee
United States
37232

Status

Active, not recruiting

Source

Vanderbilt University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:48:49-0400

Clinical Trials [32 Associated Clinical Trials listed on BioPortfolio]

Plasma Citrulline Concentration in Tropical Enteropathy

Citrulline is an amino acid produced in the intestine and in the liver, but the liver does not contribute significantly to circulating citrulline concentrations. The intestine is thus the ...

Effect of L-Citrulline on Vascular Function

The objective of this project is to determine the importance of peripheral vascular function on gait performance in older adults.

Immuno Nutrition by L-citrulline for Critically Ill Patients

The main objective of this study is to demonstrate that the only administration of L-citrulline, can improve immune functions in critically ill patients at high risk of nosocomial infectio...

Citrulline Supplementation Combined With Exercise: Effect on Muscle Function in Elderly People (CITEX Study)

The main objective of this study is to determine if oral supplementation of Citrulline, when combined with walking training, can produce significant changes in body composition, muscular f...

L-citrulline and Metformin in Becker's Muscular Dystrophy

The purpose of the study is to compare the effects of L-citrulline and metformin and their combination therapy on muscle function and force in patients with Becker muscular dystrophy (BMD)...

PubMed Articles [13230 Associated PubMed Articles listed on BioPortfolio]

Accumulation of citrulline by microbial arginine metabolism during the alcoholic fermentation of soy sauce.

Citrulline, the major precursor of ethyl carbamate in soy sauce, is an intermediate catabolite of arginine produced by bacteria present in soy sauce moromi mash. Pediococcus acidilactici is responsibl...

Experience of correcting endothelial dysfunction in children-residents of radioactively contaminated areas by nitric oxide potential donator citrulline.

to determine the effectiveness of citrulline use for correcting endothelial dysfunction in children resi dents of radioactively contaminated areas.

The benefits of a low dose complex carbohydrate/citrulline electrolyte solution for preoperative carbohydrate loading: Focus on glycemic variability.

Perioperative insulin resistance is associated with significant hyperglycemia-related morbidity in patients undergoing major surgery. We sought to assess the effect of preoperative loading with a low-...

Impact of L-citrulline supplementation on oxygen uptake kinetics during walking.

Supplementation with L-citrulline (Cit) has been shown to improve muscle oxygenation and oxygen uptake (VO2) kinetics during moderate-to-high intensity cycling in young men. The aim of this study was ...

Does L-citrulline supplementation improve exercise blood flow in older adults?

L-citrulline (Cit) increases arginine (Arg), the primary substrate for nitric oxide biosynthesis. We tested the hypothesis that muscle blood flow during exercise would be enhanced by Cit supplementati...

Medical and Biotech [MESH] Definitions

A urea cycle enzyme that catalyzes the formation of orthophosphate and L-citrulline (CITRULLINE) from CARBAMOYL PHOSPHATE and L-ornithine (ORNITHINE). Deficiency of this enzyme may be transmitted as an X-linked trait. EC 2.1.3.3.

A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

An NADPH-dependent enzyme that catalyzes the conversion of L-ARGININE and OXYGEN to produce CITRULLINE and NITRIC OXIDE.

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