Licorice Root Extract and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Prostate Cancer
Interventions:	Dietary Supplement: licorice root extract; Drug: docetaxel

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Ten subjects were enrolled from April 2004 through November 2006 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center, and one of its affiliate hospitals within the CINJ Oncology Group.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Licorice Root Extract and Docetaxel	licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle. docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle.

Participant Flow:   Overall Study

	Licorice Root Extract and Docetaxel
STARTED	10
COMPLETED	10
NOT COMPLETED	0

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Licorice Root Extract and Docetaxel	licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle. docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle.

Baseline Measures

	Licorice Root Extract and Docetaxel
Overall Participants Analyzed; [Units: Participants]	10
Age; [Units: Participants]
<=18 years	0
Between 18 and 65 years	4
>=65 years	6
Age; [Units: Years]; Mean (Standard Deviation)	70 (10.3)
Gender; [Units: Participants]
Female	0
Male	10
Region of Enrollment; [Units: Participants]
United States	10

  Outcome Measures

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1. Primary:

Percentage of Patients With PSA Response [ Time Frame: 7 years ]

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2. Secondary:

Proportion of Patients With a Decrease in BCL-2 Levels in PBMC and in the Degree of Plasma ER Receptor, Between Patients Who Responded to Treatment and Patients Who Did Not [ Time Frame: 7 years ]

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  

Name/Title: Dr. Robert DiPaola, MD
Organization: Rutgers Cancer Institute of New Jersey
phone: 732-235-8675
e-mail: dipaolrs@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu

Responsible Party:	Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:	NCT00176631 History of Changes
Other Study ID Numbers:	CDR0000539682; P30CA072720 ( U.S. NIH Grant/Contract ); 0220034593 ( Other Identifier: UMDNJ IRB ); CINJ 080306 ( Other Identifier: CINJ )
First Submitted:	September 13, 2005
First Posted:	September 15, 2005
Results First Submitted:	November 15, 2013
Results First Posted:	January 7, 2014
Last Update Posted:	January 7, 2014