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

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ClinicalTrials.gov Identifier: NCT00176631
Recruitment Status : Terminated (slow accrual)
First Posted : September 15, 2005
Results First Posted : January 7, 2014
Last Update Posted : January 7, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Dietary Supplement: licorice root extract
Drug: docetaxel
Enrollment 10
Recruitment Details 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  
Arm/Group Title Licorice Root Extract and Docetaxel
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Licorice Root Extract and Docetaxel
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  40.0%
>=65 years
6
  60.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
70  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
0
   0.0%
Male
10
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Percentage of Patients With PSA Response
Hide Description Decline from baseline value by > 50%, or normalization of PSA (defined as PSA less than 0.2 ng/ml), confirmed by a second measurement at least 1 or more weeks later.
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.
Arm/Group Title Licorice Root Extract and Docetaxel
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.
Arm/Group Title Licorice Root Extract and Docetaxel
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 7 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Licorice Root Extract and Docetaxel
Hide Arm/Group Description

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.

All-Cause Mortality
Licorice Root Extract and Docetaxel
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Licorice Root Extract and Docetaxel
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
General disorders   
Fatigue (lethargy, malaise, asthenia) * 1  1/10 (10.00%)  1
Psychiatric disorders   
Confusion * 1  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Licorice Root Extract and Docetaxel
Affected / at Risk (%) # Events
Total   9/10 (90.00%)    
Blood and lymphatic system disorders   
Leukocytes (total WBC) * 1  6/10 (60.00%)  22
Neutrophils/granulocytes (ANC/AGC) * 1  6/10 (60.00%)  24
Hemoglobin * 1  3/10 (30.00%)  6
Cardiac disorders   
Edema * 1  3/10 (30.00%)  3
Hypotension * 1  1/10 (10.00%)  2
Ear and labyrinth disorders   
Auditory/Hearing - Other * 1  1/10 (10.00%)  1
Gastrointestinal disorders   
Diarrhea patients without colostomy * 1  3/10 (30.00%)  5
Anorexia * 1  2/10 (20.00%)  2
Dehydration * 1  2/10 (20.00%)  2
Nausea * 1  2/10 (20.00%)  3
Dysphagia, esophagitis, odynophagia (painful swallowing) * 1  1/10 (10.00%)  2
Taste disturbance (dysgeusia) * 1  1/10 (10.00%)  1
Rectal bleeding/hematochezia * 1  1/10 (10.00%)  1
General disorders   
Fatigue (lethargy, malaise, asthenia) * 1  8/10 (80.00%)  11
Constitutional Symptoms - Other * 1  1/10 (10.00%)  1
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) * 1  1/10 (10.00%)  1
Sweating (diaphoresis) * 1  1/10 (10.00%)  1
Pain * 1  4/10 (40.00%)  4
Bone pain * 1  1/10 (10.00%)  1
Infections and infestations   
Infection without neutropenia * 1  1/10 (10.00%)  2
Investigations   
Hypermagnesemia * 1  1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness (not due to neuropathy) * 1  1/10 (10.00%)  1
Nervous system disorders   
Neuropathy-sensory * 1  2/10 (20.00%)  2
Dizziness/lightheadedness * 1  1/10 (10.00%)  1
Insomnia * 1  1/10 (10.00%)  1
Psychiatric disorders   
Confusion * 1  1/10 (10.00%)  2
Renal and urinary disorders   
Incontinence * 1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 1  2/10 (20.00%)  2
Dyspnea (shortness of breath) * 1  2/10 (20.00%)  2
Skin and subcutaneous tissue disorders   
Alopecia * 1  1/10 (10.00%)  1
Dermatology/Skin - Other * 1  1/10 (10.00%)  1
Rash/desquamation * 1  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert DiPaola, MD
Organization: Rutgers Cancer Institute of New Jersey
Phone: 732-235-8675
EMail: dipaolrs@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu
Layout table for additonal information
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00176631    
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