Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 71 of 1543 for:    Androgens

EXTEND Exercise Trial

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: NCT02256111
Recruitment Status : Completed
First Posted : October 3, 2014
Results First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-metastatic, Hormone naïve Prostate Cancer
Interventions Drug: Enzalutamide
Drug: Androgen deprivation therapy
Behavioral: Supervised exercise training
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Period Title: Overall Study
Started 13 13
Completed 13 13
Not Completed 0 0
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise Total
Hide Arm/Group Description

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
64.37  (8.31) 65.66  (8.11) 65.01  (8.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
13
 100.0%
13
 100.0%
26
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
13
 100.0%
13
 100.0%
26
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   7.7%
0
   0.0%
1
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  15.4%
2
  15.4%
4
  15.4%
White
10
  76.9%
10
  76.9%
20
  76.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   7.7%
1
   3.8%
1.Primary Outcome
Title Change in VO2peak in Usual Care Versus Exercise Training Arms
Hide Description Mean change in peak oxygen uptake (VO2peak) from week 1 to week 17 in the usual care and exercise training groups
Time Frame From week 1 to week 17
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: mL/kg/min
-3.23  (5.02) -0.92  (2.4)
2.Secondary Outcome
Title 17-week Change in Functional Capacity as Measured by Chair-stand Test
Hide Description Mean change in number of seconds to perform the chair-stand test between baseline and week 17. This test measures the time taken to complete 5 repetitions of the sit-to-stand maneuver from a chair without an arm rest at 43 cm in height and 47.5 cm in depth. This test provides an indicator of functional performance of lower body strength; quicker times indicate greater strength
Time Frame Baseline to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One patient in the usual care arm did not complete the test at week 17
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: seconds
-1.08  (2.29) -0.78  (1.7)
3.Secondary Outcome
Title 17-week Change in Upper and Lower Extremity Maximal Muscular Strength
Hide Description Mean change in upper and lower extremity maximal muscular strength as measured by the voluntary one-repetition max (1-RM) and muscular endurance as measured by 70% of 1-RM between week 17 and baseline
Time Frame Baseline to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient out of 13 did not complete the 1-RM at baseline or week 17 in the usual care arm, and another did not complete the 70% 1-RM at week 17 out of 12
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: pounds
Change in Leg Press 1-RM 6.67  (83.99) 107.8  (105.75)
Change in Leg Press 70% 1-RM 10  (57.4) 74.92  (74.05)
Change in Chest Press 1-RM 5.08  (24.96) 24.31  (24.99)
Change in Chest Press 70% 1-RM 6.73  (13.93) 17  (17.32)
Change in Seated Row 1-RM 2.25  (20.86) 14.85  (23.39)
Change in Seated Row 70% 1-RM -0.27  (18.29) 10.46  (16.47)
4.Secondary Outcome
Title Effects on Serum Glucose
Hide Description Mean change in fasting serum glucose between week 17 and baseline.
Time Frame Baseline to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only 10 in the usual care and 8 in the exercise arm patients had glucose measurements at both baseline and week 17.
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: mg/dL
5.3  (16.22) -1  (5.55)
5.Secondary Outcome
Title Change in the Effect on Patient Reported Outcomes (PROs) of Interest Over Time
Hide Description Mean change in PROs aggregate score between week 17 and baseline. PROs include the FACT-Prostate (FACT-P, range 0 to 104), FACIT-Fatigue (FACIT-F, range 0 to 52), and the Godin Leisure Questionnaire. Higher scores indicate better quality of life.
Time Frame Baseline to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
FACIT-Fatigue score -9.15  (11.25) -5  (4.88)
FACT-Prostate Trial Outcome Index -11.61  (14.39) -5.38  (9.01)
Godin Leisure score 4.67  (26.2) 9.33  (17.55)
6.Secondary Outcome
Title Eligibility Rate
Hide Description Eligibility rate is defined as the number of subjects found to be eligible divided by the number approached for the study. Note that ineligible subjects are not randomized. This is reported as a percent.
Time Frame 29 months from study initiation
Hide Outcome Measure Data
Hide Analysis Population Description
This overall number of participants analyzed reflects the total number of individuals approached for this study.
Arm/Group Title Approached Subjects
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: percentage of participants
87
7.Secondary Outcome
Title Acceptance Rate
Hide Description Acceptance rate is defined as the number of patients agreeing to participate divided by total number randomized. This is reported as a percent.
Time Frame 29 months from study initiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 13 13
Measure Type: Number
Unit of Measure: percentage of participants
100 100
8.Secondary Outcome
Title Adherence Rate
Hide Description Adherence rate is defined as the percentage of days that each patient fulfilled the assigned exercise prescription of the 48 days. The median percentage is reported.
Time Frame 48 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 13 13
Median (Full Range)
Unit of Measure: percentage of days
NA [1] 
(NA to NA)
95.8
(81.2 to 100)
[1]
Adherence rate does not apply to the usual care arm.
9.Secondary Outcome
Title Attrition Rate
Hide Description Attrition rate is defined as the percent of subjects who complete the 16 week exercise training program. This outcome applies only to the exercise arm.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 13 13
Measure Type: Number
Unit of Measure: percentage of participants
NA [1]  100
[1]
Attrition rate does not apply to the usual care arm.
10.Secondary Outcome
Title 17-week Change in Functional Capacity as Measured by Time Up and Go Test
Hide Description Mean change in number of seconds to complete the timed up and go test between week 17 and baseline. This test requires patients to stand up from a chair with armrests, walk 3m, turn around, return to the chair, and sit down
Time Frame Baseline to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One patient in the usual care arm did not complete the test at week 17
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: seconds
0.33  (1.07) 0.08  (0.95)
11.Secondary Outcome
Title 17-week Change in Functional Capacity as Measured by Six Minute Walk Test
Hide Description Mean change in distance covered during the six minute walk test between week 17 and baseline. This test requires patients to cover the longest distance possible in six minutes under the supervision of an exercise physiologist or designee.
Time Frame Baseline to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients in the usual care arm did not complete the test at both baseline and week 17
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 11 13
Mean (Standard Deviation)
Unit of Measure: meters
-32.02  (58.47) 42  (60.26)
12.Secondary Outcome
Title 17-week Change in Muscle Cross-sectional Area (CSA)
Hide Description Mean change in muscle cross sectional area of the dominant quadricep, hamstring, and total mid-thigh between week 17 and baseline. Cross-sectional area was measured using magnetic resonance imaging with a 3.0T-scanner.
Time Frame Baseline to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only 10 in the usual care and 8 in the exercise arm patients had cross-sectional area measurements performed at both measurement time points.
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: cm^2
Change in quadricep CSA -4.84  (4.03) -4.03  (3.24)
Change in hamstring CSA -4.8  (5.32) -5.09  (4.04)
Change in total mid-thigh CSA -9.43  (6.12) -9.12  (7.01)
13.Secondary Outcome
Title Effects on Serum Insulin
Hide Description Mean change in fasting serum insulin between week 17 and baseline.
Time Frame Baseline to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only 10 in the usual care and 8 in the exercise arm patients had insulin measurements at both baseline and week 17.
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: u[iU]/mL
2.61  (5.06) 0  (11.05)
14.Secondary Outcome
Title Effects on Blood Hemoglobin (Hgb)
Hide Description Mean change in blood hemoglobin (Hgb) A1C between week 17 and baseline.
Time Frame Baseline to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only 10 in the usual care and 8 in the exercise arm patients had Hgb measurements at both baseline and week 17.
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: percentage of glycated hemoglobin
-0.04  (0.39) 1.15  (2.81)
15.Secondary Outcome
Title Effects on Body Composition
Hide Description Mean change in lean body mass and fat body mass between week 17 and baseline as measured by a DEXA Scan.
Time Frame Baseline to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description:

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: g
Change in lean body mass -3087.92  (3799.02) -2094.42  (2407.27)
Change in fat body mass 2949.36  (3944.65) -121.45  (2435.41)
Time Frame 37 weeks
Adverse Event Reporting Description Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
 
Arm/Group Title ENZ+ADT+Usual Care ENZ+ADT+Exercise
Hide Arm/Group Description

The usual care arm will receive treatment with enzalutamide with androgen deprivation therapy, with no supervised exercise training.

Enzalutamide

Androgen deprivation therapy

The ENZ+ADT+Exercise arm will receive treatment with enzalutamide plus androgen deprivation therapy along with supervised exercise training.

Enzalutamide

Androgen deprivation therapy

Supervised exercise training

All-Cause Mortality
ENZ+ADT+Usual Care ENZ+ADT+Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
ENZ+ADT+Usual Care ENZ+ADT+Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   4/13 (30.77%)   0/13 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  1/13 (7.69%)  0/13 (0.00%) 
Cardiac disorders - Other, Specify: RIGHT CORONARY ARTERY STENOSIS (90% OCCULUSION)  1  1/13 (7.69%)  0/13 (0.00%) 
Gastrointestinal disorders     
Colonic obstruction  1  1/13 (7.69%)  0/13 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Other, Specify: SURGICAL PROCEDURE FOR INVASIVE ADENOCARCINOMA OF COLON  1  1/13 (7.69%)  0/13 (0.00%) 
Surgical and medical procedures     
Surgical and medical procedures - Other, Specify: INGUINAL HERNIA REPAIR, LAPAROSCOPIC  1  1/13 (7.69%)  0/13 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ENZ+ADT+Usual Care ENZ+ADT+Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   13/13 (100.00%)   13/13 (100.00%) 
Cardiac disorders     
Other, Specify: ABNORMAL ECG  1  1/13 (7.69%)  0/13 (0.00%) 
Other, Specify: ST DEPRESSION  1  1/13 (7.69%)  0/13 (0.00%) 
Chest pain - cardiac  1  2/13 (15.38%)  0/13 (0.00%) 
Palpitations  1  1/13 (7.69%)  0/13 (0.00%) 
Sinus bradycardia  1  0/13 (0.00%)  1/13 (7.69%) 
Ear and labyrinth disorders     
Tinnitus  1  1/13 (7.69%)  0/13 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/13 (7.69%)  0/13 (0.00%) 
Bloating  1  1/13 (7.69%)  0/13 (0.00%) 
Diarrhea  1  1/13 (7.69%)  0/13 (0.00%) 
Dry mouth  1  1/13 (7.69%)  0/13 (0.00%) 
Dyspepsia  1  4/13 (30.77%)  1/13 (7.69%) 
Flatulence  1  1/13 (7.69%)  1/13 (7.69%) 
Other, Specify: "BURPING"  1  1/13 (7.69%)  0/13 (0.00%) 
Other, Specify: STOMACH SPASMS  1  1/13 (7.69%)  0/13 (0.00%) 
Gingival pain  1  0/13 (0.00%)  1/13 (7.69%) 
Nausea  1  3/13 (23.08%)  3/13 (23.08%) 
Oral pain  1  0/13 (0.00%)  1/13 (7.69%) 
Stomach pain  1  1/13 (7.69%)  0/13 (0.00%) 
Toothache  1  1/13 (7.69%)  0/13 (0.00%) 
Vomiting  1  1/13 (7.69%)  0/13 (0.00%) 
General disorders     
Chills  1  0/13 (0.00%)  1/13 (7.69%) 
Fatigue  1  11/13 (84.62%)  10/13 (76.92%) 
Flu like symptoms  1  0/13 (0.00%)  1/13 (7.69%) 
Irritability  1  2/13 (15.38%)  1/13 (7.69%) 
Localized edema  1  1/13 (7.69%)  0/13 (0.00%) 
Malaise  1  0/13 (0.00%)  1/13 (7.69%) 
Non-cardiac chest pain  1  0/13 (0.00%)  1/13 (7.69%) 
Pain  1  3/13 (23.08%)  2/13 (15.38%) 
Infections and infestations     
Other, Specify: SURGICAL WOUND INFECTION FOLLOWING HERNIA REPAIR  1  1/13 (7.69%)  0/13 (0.00%) 
Mucosal infection  1  1/13 (7.69%)  0/13 (0.00%) 
Sinusitis  1  1/13 (7.69%)  0/13 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  0/13 (0.00%)  2/13 (15.38%) 
Investigations     
Alanine aminotransferase increased  1  1/13 (7.69%)  0/13 (0.00%) 
Aspartate aminotransferase increased  1  1/13 (7.69%)  0/13 (0.00%) 
Weight gain  1  1/13 (7.69%)  0/13 (0.00%) 
Weight loss  1  2/13 (15.38%)  1/13 (7.69%) 
Metabolism and nutrition disorders     
Dehydration  1  1/13 (7.69%)  0/13 (0.00%) 
Hypercalcemia  1  1/13 (7.69%)  0/13 (0.00%) 
Hyperkalemia  1  2/13 (15.38%)  0/13 (0.00%) 
Hyponatremia  1  1/13 (7.69%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/13 (7.69%)  0/13 (0.00%) 
Arthritis  1  0/13 (0.00%)  1/13 (7.69%) 
Generalized muscle weakness  1  1/13 (7.69%)  0/13 (0.00%) 
Other, Specify: LEG SPASMS  1  1/13 (7.69%)  0/13 (0.00%) 
Other, Specify: MUSCLE CRAMPS  1  1/13 (7.69%)  0/13 (0.00%) 
Other, Specify: WEAKNESS IN EXTREMITIES  1  1/13 (7.69%)  0/13 (0.00%) 
Myalgia  1  1/13 (7.69%)  3/13 (23.08%) 
Neck pain  1  1/13 (7.69%)  0/13 (0.00%) 
Pain in extremity  1  2/13 (15.38%)  4/13 (30.77%) 
Nervous system disorders     
Cognitive disturbance  1  2/13 (15.38%)  2/13 (15.38%) 
Concentration impairment  1  1/13 (7.69%)  0/13 (0.00%) 
Dizziness  1  2/13 (15.38%)  3/13 (23.08%) 
Dysarthria  1  1/13 (7.69%)  0/13 (0.00%) 
Dysgeusia  1  0/13 (0.00%)  1/13 (7.69%) 
Headache  1  3/13 (23.08%)  3/13 (23.08%) 
Hypersomnia  1  1/13 (7.69%)  0/13 (0.00%) 
Memory impairment  1  1/13 (7.69%)  1/13 (7.69%) 
Other, Specify: INTERMITTENT SLEEP DISTURBANCE  1  1/13 (7.69%)  0/13 (0.00%) 
Other, Specify: VIVID DREAMS  1  0/13 (0.00%)  1/13 (7.69%) 
Paresthesia  1  0/13 (0.00%)  2/13 (15.38%) 
Tremor  1  0/13 (0.00%)  1/13 (7.69%) 
Psychiatric disorders     
Agitation  1  1/13 (7.69%)  0/13 (0.00%) 
Anxiety  1  2/13 (15.38%)  0/13 (0.00%) 
Depression  1  0/13 (0.00%)  1/13 (7.69%) 
Insomnia  1  5/13 (38.46%)  6/13 (46.15%) 
Libido decreased  1  0/13 (0.00%)  1/13 (7.69%) 
Other, Specify: MOODY  1  1/13 (7.69%)  0/13 (0.00%) 
Other, Specify: SLEEP DISTURBANCE - NIGHTMARES  1  1/13 (7.69%)  0/13 (0.00%) 
Restlessness  1  1/13 (7.69%)  0/13 (0.00%) 
Renal and urinary disorders     
Other, Specify: TROUBLE STARTING STREAM  1  0/13 (0.00%)  1/13 (7.69%) 
Urinary frequency  1  3/13 (23.08%)  3/13 (23.08%) 
Urinary incontinence  1  1/13 (7.69%)  1/13 (7.69%) 
Urinary tract pain  1  0/13 (0.00%)  1/13 (7.69%) 
Urinary urgency  1  2/13 (15.38%)  1/13 (7.69%) 
Reproductive system and breast disorders     
Erectile dysfunction  1  0/13 (0.00%)  1/13 (7.69%) 
Gynecomastia  1  1/13 (7.69%)  0/13 (0.00%) 
Other, Specify: ERECTION LASTING 14-16 HOURS, NON-PAINFUL.  1  1/13 (7.69%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  2/13 (15.38%)  2/13 (15.38%) 
Hoarseness  1  0/13 (0.00%)  1/13 (7.69%) 
Nasal congestion  1  1/13 (7.69%)  1/13 (7.69%) 
Postnasal drip  1  1/13 (7.69%)  0/13 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  1/13 (7.69%)  0/13 (0.00%) 
Dry skin  1  2/13 (15.38%)  2/13 (15.38%) 
Pruritus  1  0/13 (0.00%)  2/13 (15.38%) 
Rash maculo-papular  1  2/13 (15.38%)  0/13 (0.00%) 
Other, Specify: ABDOMINAL RASH  1  0/13 (0.00%)  1/13 (7.69%) 
Other, Specify: NIGHT SWEATS  1  1/13 (7.69%)  0/13 (0.00%) 
Other, Specify: PENIS LESION  1  0/13 (0.00%)  1/13 (7.69%) 
Other, Specify: PUBIC HAIR LOSS (R/T RADIATION THERAPY)  1  1/13 (7.69%)  0/13 (0.00%) 
Surgical and medical procedures     
Other, Specify: NUMBNESS IN LOWER RIGHT LIP  1  0/13 (0.00%)  1/13 (7.69%) 
Vascular disorders     
Hot flashes  1  12/13 (92.31%)  13/13 (100.00%) 
Hypertension  1  3/13 (23.08%)  1/13 (7.69%) 
Hypotension  1  2/13 (15.38%)  0/13 (0.00%) 
Other, Specify  1  0/13 (0.00%)  1/13 (7.69%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
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: Michael Harrison, MD
Organization: Duke University
Phone: 919-668-4615
EMail: michael.harrison@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02256111     History of Changes
Other Study ID Numbers: Pro00053924
First Submitted: August 22, 2014
First Posted: October 3, 2014
Results First Submitted: February 21, 2019
Results First Posted: April 18, 2019
Last Update Posted: April 18, 2019