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Breast Neoplasms, Male

Breast Diseases

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Breast Cancer, Male

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Docetaxel

Tubulin Modulators

Antimitotic Agents

Garlic

garlic

docetaxel

Michael C. Cox, PharmD

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether garlic supplements affect the ability of docetaxel to kill tumor cells.

PURPOSE: This clinical trial is studying how well giving docetaxel together with garlic works in treating patients with locally advanced or metastatic breast cancer.

OBJECTIVES:

Primary

* Determine the clinical pharmacokinetic behavior of docetaxel with and without garlic tablets in patients with locally advanced or metastatic breast cancer.
* Determine the toxicity of this regimen in these patients.

Secondary

* Determine the incidence of enzyme and transporter polymorphism in patients treated with this regimen.

OUTLINE: This is a pilot, open-label study.

Patients receive docetaxel IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. On days 5-17 of course 1, patients receive oral garlic twice daily. Patients have the option of continuing garlic tablets as long as they remain on study.

PROJECTED ACCRUAL: A total of 9-12 patients will be accrued for this study within 6 months.

Docetaxel Plus Garlic in Treating Patients With Locally Advanced or Metastatic Breast Cancer

A Pilot Study to Evaluate the Influence of Garlic on the Pharmacokinetics of Docetaxel in Patients With Metastatic Breast Cancer

National Cancer Institute (NCI)

270 kcal white bread with 15 g margarine and 5 g crushed garlic

Subjects will consume a garlic-free diet for 10 days. On day 11, subjects will consume 270 kcal white bread with 15 g margarine.

Control

Subjects will consume a garlic-free diet for 10 days. On day 11, subjects will consume 270 kcal white bread with 15 g margarine and 5 g crushed garlic.

Garlic treatment

This study is being done to study the healthful benefits of eating garlic. Previous studies suggest that garlic may help prevent cancer. The investigators are recruiting healthy volunteers to participate in a study to determine the ways in which eating garlic may reduce cancer risk.

A crossover design will be utilized with each participant completing each treatment phase; participants will be randomly assigned to a sequence of dietary treatments. There will be a 17-day washout period in between diet periods. Participants will consume a garlic-free diet for the first 10 days of each diet period. The dietary treatments will be administered on day 11 of each diet period. Dietary treatments will be incorporated into food as follows: 1) 5 g (0.175 oz.) of garlic mixed with 15 g margarine on top of 270 kcal white bread, served as breakfast, or 2) 15 g margarine on top of 270 kcal white bread, served as breakfast.

Garlic Intake And Biomarkers Of Cancer Risk

Garlic metabolites will be measured in blood and urine.

Lymphocyte microarray analysis, lymphocyte DNA genotyping. Microarray results will be confirmed by RT-PCR.

Serum nitrate/nitrite, malondyaldehyde, glutathione, glutathione reductase, glutathione S-transferase, catalase, protein carbonyls, F2-isoprostanes.

C-reactive protein (CRP), vascular endothelial growth factor, IL-1, IL-6, TNF-α.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Docetaxel Plus Garlic in Treating Patients With Locally Advanced or Metastatic Breast Cancer	NCT00079170	Breast Cancer	garlic docetaxel	18 Years -	National Cancer Institute (NCI)
Docetaxel Plus Garlic in Treating Patients With Locally Advanced or Metastatic Breast Cancer	NCT00079170	Breast Cancer	garlic docetaxel	18 Years -	National Cancer Institute (NCI)
Garlic Intake And Biomarkers Of Cancer Risk	NCT01293591	Healthy Men Healthy Women	Control Garlic treatmen...	40 Years - 80 Years	USDA Beltsville Human Nutrition Research Center

Spots Global Cancer Trial Database for garlic

Every month we try and update this database with for garlic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for garlic

Every month we try and update this database with for garlic cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for garlic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.