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Digoxin for Recurrent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01162135
Recruitment Status : Completed
First Posted : July 14, 2010
Results First Posted : June 5, 2014
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Digoxin
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Digoxin
Hide Arm/Group Description Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
Period Title: Overall Study
Started 16
Completed 13
Not Completed 3
Reason Not Completed
Withdrawal by Subject             1
Severe back pain             1
Ineligible             1
Arm/Group Title Digoxin
Hide Arm/Group Description Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
67.5  (9.5)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  50.0%
>=65 years
8
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
0
   0.0%
Male
16
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  12.5%
White
13
  81.3%
More than one race
0
   0.0%
Unknown or Not Reported
1
   6.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Hispanic or Latino
2
  12.5%
Not Hispanic or Latino
14
  87.5%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Rate of Positive PSADT Outcome
Hide Description Proportion of patients at 6 months post-treatment with a PSADT >= 200% from baseline
Time Frame 6 months after treatment with digoxin
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Digoxin
Hide Arm/Group Description:
Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Digoxin
Hide Arm/Group Description Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
All-Cause Mortality
Digoxin
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Digoxin
Affected / at Risk (%) # Events
Total   0/16 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Digoxin
Affected / at Risk (%) # Events
Total   16/16 (100.00%)    
Blood and lymphatic system disorders   
Hyperkalemia  2/16 (12.50%)  4
Hyperglycemia  3/16 (18.75%)  6
Hypoglycemia  1/16 (6.25%)  2
Hypophosphatemia  1/16 (6.25%)  1
Lymphopenia  1/16 (6.25%)  1
Hyponatremia  1/16 (6.25%)  1
Hypomagnesemia  1/16 (6.25%)  1
Hyperbilirubinemia  1/16 (6.25%)  2
Bicarbonate low  1/16 (6.25%)  1
Hypertension  2/16 (12.50%)  3
Cardiac disorders   
Bradycardia  1/16 (6.25%)  1
Heart palpitations  1/16 (6.25%)  1
EKG change  3/16 (18.75%)  4
Sinus brachycardia  1/16 (6.25%)  1
Gastrointestinal disorders   
Epigastric discomfort  1/16 (6.25%)  1
Vomiting  2/16 (12.50%)  2
Indigestion  1/16 (6.25%)  1
Diarrhea  1/16 (6.25%)  1
Acid reflux  1/16 (6.25%)  1
Constipation  1/16 (6.25%)  1
General disorders   
Dizziness  2/16 (12.50%)  2
Change in taste  1/16 (6.25%)  1
Incontinence  1/16 (6.25%)  1
Decreased appetite  2/16 (12.50%)  3
Cold/cough  3/16 (18.75%)  3
Fatigue  3/16 (18.75%)  3
Loose stools  2/16 (12.50%)  2
Decreased energy  1/16 (6.25%)  1
Lightheadedness  2/16 (12.50%)  2
Neck pain  2/16 (12.50%)  2
Arm pain  1/16 (6.25%)  1
Foot pain  1/16 (6.25%)  1
Numbness/cramping of lower legs  1/16 (6.25%)  1
Abdominal pain  1/16 (6.25%)  1
Nausea  2/16 (12.50%)  2
Headaches  1/16 (6.25%)  1
Back pain  2/16 (12.50%)  3
Vivid dreams  3/16 (18.75%)  3
Insomnia  2/16 (12.50%)  2
Low libido  1/16 (6.25%)  1
Side pain  1/16 (6.25%)  1
Rib pain  1/16 (6.25%)  1
Shoulder pain  1/16 (6.25%)  1
Tooth root canal  1/16 (6.25%)  1
Nightmares  1/16 (6.25%)  2
Hepatobiliary disorders   
ALT high  2/16 (12.50%)  3
Infections and infestations   
Tooth infection  1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders   
Arthritis  1/16 (6.25%)  1
Knee achiness  1/16 (6.25%)  2
Renal and urinary disorders   
Hematuria  2/16 (12.50%)  4
Urinary tract infection  1/16 (6.25%)  1
Nocturia  1/16 (6.25%)  1
Reproductive system and breast disorders   
Testicular soreness  1/16 (6.25%)  1
Erectile dysfunction  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Upper respiratory infection  2/16 (12.50%)  2
Difficulty raking deep breaths  1/16 (6.25%)  1
Skin and subcutaneous tissue disorders   
Edema  2/16 (12.50%)  2
Boil on finger  1/16 (6.25%)  1
Poison ivy  1/16 (6.25%)  1
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: Jianqing Lin, MD
Organization: Thomas Jefferson University
Phone: 215-955-8874
EMail: Jianqing.Lin@jefferson.edu
Layout table for additonal information
Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT01162135    
Other Study ID Numbers: 10G.87
2009-43 ( Other Identifier: CCRRC )
First Submitted: July 12, 2010
First Posted: July 14, 2010
Results First Submitted: April 23, 2014
Results First Posted: June 5, 2014
Last Update Posted: November 29, 2016