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Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00809458
Recruitment Status : Terminated (Low rate of accrual.)
First Posted : December 17, 2008
Results First Posted : June 23, 2015
Last Update Posted : July 16, 2015
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Vitamin E
Enrollment 15
Recruitment Details Patients were recruited at oncology clinics between December 2008 and April 2010. The study was terminated due to low accrual rate.
Pre-assignment Details One subject suffered an unrelated bone fracture prior to study start, and another was determined to have metastatic disease. 71 participants were screened. 31 did not meet criteria; 25 refused study entry. 15 were enrolled
Arm/Group Title Arm 1 (Vitamin E) Arm 2 (Placebo)
Hide Arm/Group Description Vitamin E administration: one 400 IU tablet of vitamin E daily Placebo (same vehicle as used for vitamin E): one placebo tablet daily
Period Title: Overall Study
Started 9 6
Completed 8 5
Not Completed 1 1
Arm/Group Title Arm 1 (Vitamin E) Arm 2 (Placebo) Total
Hide Arm/Group Description Vitamin E administration: one 400 IU tablet of vitamin E daily Placebo (same vehicle as used for vitamin E): one placebo tablet daily Total of all reporting groups
Overall Number of Baseline Participants 9 6 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  77.8%
4
  66.7%
11
  73.3%
>=65 years
2
  22.2%
2
  33.3%
4
  26.7%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants 6 participants 15 participants
60
(51 to 73)
60.5
(52 to 66)
60
(51 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
9
 100.0%
6
 100.0%
15
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 6 participants 15 participants
9 6 15
1.Primary Outcome
Title Reduce Biomarkers of Prostate Cancer (PSA Blood Level)
Hide Description PSA levels will be measured as a sensitive marker of anti-androgenic activity that is a critical endpoint to be measured in this study. PSA blood levels will be determined at the initiation and completion of Vitamin E supplementation from blood obtained at these time points. A clinical reference laboratory will perform blood PSA analysis and will be compared with plasma cholesterol levels as a relative control.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.
Arm/Group Title Arm 1 (Vitamin E) Arm 2 (Placebo)
Hide Arm/Group Description:
Vitamin E administration: one 400 IU tablet of vitamin E daily
Placebo (same vehicle as used for vitamin E): one placebo tablet daily
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Determine the Tolerability/Toxicity of a Short Course of Vitamin E in the Neoadjuvant Setting.
Hide Description
  1. Cardiovascular Effects/ Thrombophlebitis
  2. Dermatologic Effects
  3. Gastrointestinal Effects (Gingival bleeding, and gastrointestinal irritations including: diarrhea, nausea, flatulence and stomach cramps)
  4. Hematologic Effects (Increased bleeding tendencies in vitamin K deficient patients; inhibition of prothrombin production
  5. Hepatic Effects (Vasculopathic hepatotoxicity and cholestasis)
  6. Neurologic Effects (Dizziness, headache, fatigue or weakness
  7. Ophthalmic Effects ( Blurred vision)
  8. Respiratory Effects (Pulmonary embolism)
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.
Arm/Group Title Arm 1 (Vitamin E) Arm 2 (Placebo)
Hide Arm/Group Description:
Vitamin E administration: one 400 IU tablet of vitamin E daily
Placebo (same vehicle as used for vitamin E): one placebo tablet daily
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Determine Concordance of the Biomarkers in This Setting
Hide Description The correlation between the ATQ level and the androgen receptor will be explored.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.
Arm/Group Title Arm 1 (Vitamin E) Arm 2 (Placebo)
Hide Arm/Group Description:
Vitamin E administration: one 400 IU tablet of vitamin E daily
Placebo (same vehicle as used for vitamin E): one placebo tablet daily
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Subjects were followed from the start of treatment until 30 days after prostatectomy or brachytherapy.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 (Vitamin E) Arm 2
Hide Arm/Group Description

Vitamin E

Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy.

Placebo (same vehicle as used for vitamin E)

Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy.

All-Cause Mortality
Arm 1 (Vitamin E) Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 (Vitamin E) Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 (Vitamin E) Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      0/6 (0.00%)    
Cardiac disorders     
Hypotension (Low blood pressure) * 1  1/9 (11.11%)  1 0/6 (0.00%)  0
*
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: Richard Lauer, MD
Organization: UNM Cancer Center
Phone: 505-925-0390
EMail: rlauer@salud.unm.edu
Layout table for additonal information
Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00809458     History of Changes
Other Study ID Numbers: INST 0808
NCI-2011-02662 ( Registry Identifier: NCI Clinical Trials Reporting Program )
First Submitted: December 15, 2008
First Posted: December 17, 2008
Results First Submitted: June 6, 2015
Results First Posted: June 23, 2015
Last Update Posted: July 16, 2015