Trial Outcomes & Findings for Soy Protein/Effexor Hormone Therapy for Prostate Cancer (NCT NCT00354432)
NCT ID: NCT00354432
Last Updated: 2021-09-28
Results Overview
The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i.e., 100\*(12 week score)/baseline score). The range is 0 to infinity. Lower values represent a better outcome.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-09-28
Participant Flow
Participant milestones
| Measure |
Arm I - Placebo
Patients receive oral placebo pill and oral placebo powder once daily.
|
Arm II - Soy
Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
|
Arm III - Venlafaxine
Patients receive oral venlafaxine pill and oral placebo powder once daily.
|
Arm IV - Soy + Venlafaxin
Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
24
|
22
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
10
|
10
|
Reasons for withdrawal
| Measure |
Arm I - Placebo
Patients receive oral placebo pill and oral placebo powder once daily.
|
Arm II - Soy
Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
|
Arm III - Venlafaxine
Patients receive oral venlafaxine pill and oral placebo powder once daily.
|
Arm IV - Soy + Venlafaxin
Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
5
|
5
|
|
Overall Study
Off/Toxicity
|
3
|
7
|
5
|
5
|
Baseline Characteristics
Soy Protein/Effexor Hormone Therapy for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm I - Placebo
n=30 Participants
Patients receive oral placebo pill and oral placebo powder once daily.
|
Arm II - Soy
n=30 Participants
Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
|
Arm III - Venlafaxine
n=30 Participants
Patients receive oral venlafaxine pill and oral placebo powder once daily.
|
Arm IV - Soy + Venlafaxine
n=30 Participants
Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
71.0 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
68.5 years
STANDARD_DEVIATION 9.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
30 participants
n=4 Participants
|
120 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All randomized participants were analyzed in a repeated measures mixed model. This allowed inclusion of all study participants.
The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i.e., 100\*(12 week score)/baseline score). The range is 0 to infinity. Lower values represent a better outcome.
Outcome measures
| Measure |
Arm I - Placebo
n=30 Participants
Patients receive oral placebo pill and oral placebo powder once daily.
|
Arm II - Soy
n=30 Participants
Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
|
Arm III - Venlafaxine
n=30 Participants
Patients receive oral Venlafaxine pill and placebo powder once daily.
|
Arm IV - Soy + Venlafaxine
n=30 Participants
Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
|
|---|---|---|---|---|
|
Hot Flash Symptom Severity Score
|
52.3 percent of baseline score
Standard Error 10.8
|
77.2 percent of baseline score
Standard Error 11.6
|
68.9 percent of baseline score
Standard Error 12.1
|
73.8 percent of baseline score
Standard Error 11.9
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants with baseline and 12 week quality of life data.
Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate questionnaire (FACT-P). The FACT-P consists of four general subscales (functional, emotional, social, and physical) consisting of a total of 27 questions as well as a Prostate specific subscale consisting of 12 questions. Each question is answered on a 0 to 4 scale. The FACT-P score ranges from 0 to 156; higher scores denote better quality of life.
Outcome measures
| Measure |
Arm I - Placebo
n=21 Participants
Patients receive oral placebo pill and oral placebo powder once daily.
|
Arm II - Soy
n=21 Participants
Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
|
Arm III - Venlafaxine
n=18 Participants
Patients receive oral Venlafaxine pill and placebo powder once daily.
|
Arm IV - Soy + Venlafaxine
n=17 Participants
Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
|
|---|---|---|---|---|
|
Quality of Life
|
115.6 units on a scale
Standard Error 2.4
|
121.5 units on a scale
Standard Error 2.5
|
114.3 units on a scale
Standard Error 2.7
|
117.7 units on a scale
Standard Error 2.8
|
Adverse Events
Arm I - Placebo
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Arm II - Soy
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm III - Venlafaxine
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Arm IV - Soy + Venlafaxine
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I - Placebo
n=30 participants at risk
Patients receive oral placebo pill and oral placebo powder once daily.
|
Arm II - Soy
n=27 participants at risk
Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
|
Arm III - Venlafaxine
n=29 participants at risk
Patients receive oral Venlafaxine pill and placebo powder once daily.
|
Arm IV - Soy + Venlafaxine
n=28 participants at risk
Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
6.7%
2/30 • Number of events 6 • 12 weeks
|
14.8%
4/27 • Number of events 13 • 12 weeks
|
6.9%
2/29 • Number of events 8 • 12 weeks
|
14.3%
4/28 • Number of events 13 • 12 weeks
|
|
General disorders
Fatigue
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Infections and infestations
Infection - Rectum
|
0.00%
0/30 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
3.4%
1/29 • Number of events 1 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
General disorders
Insomnia
|
0.00%
0/30 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
3.6%
1/28 • Number of events 1 • 12 weeks
|
|
General disorders
Mood alteration - Agitation
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Nervous system disorders
Mood alteration- Anxiety
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Renal and urinary disorders
Obstruction - Ureter
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
General disorders
Pain - Other
|
6.7%
2/30 • Number of events 3 • 12 weeks
|
3.7%
1/27 • Number of events 1 • 12 weeks
|
3.4%
1/29 • Number of events 2 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
General disorders
Pain - chest NOS
|
0.00%
0/30 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
3.6%
1/28 • Number of events 3 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain - joint
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
General disorders
Somnolence
|
0.00%
0/30 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
3.4%
1/29 • Number of events 1 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Vascular disorders
Vascular - other
|
0.00%
0/30 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
3.6%
1/28 • Number of events 3 • 12 weeks
|
Other adverse events
| Measure |
Arm I - Placebo
n=30 participants at risk
Patients receive oral placebo pill and oral placebo powder once daily.
|
Arm II - Soy
n=27 participants at risk
Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
|
Arm III - Venlafaxine
n=29 participants at risk
Patients receive oral Venlafaxine pill and placebo powder once daily.
|
Arm IV - Soy + Venlafaxine
n=28 participants at risk
Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
|
|---|---|---|---|---|
|
General disorders
Allergic Reaction/hypersensitivity including drug reaction
|
3.3%
1/30 • Number of events 2 • 12 weeks
|
3.7%
1/27 • Number of events 4 • 12 weeks
|
6.9%
2/29 • Number of events 2 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
General disorders
Anorexia
|
13.3%
4/30 • Number of events 8 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
10.3%
3/29 • Number of events 4 • 12 weeks
|
17.9%
5/28 • Number of events 12 • 12 weeks
|
|
Nervous system disorders
Confusion
|
10.0%
3/30 • Number of events 3 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
6.9%
2/29 • Number of events 3 • 12 weeks
|
7.1%
2/28 • Number of events 2 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
40.0%
12/30 • Number of events 23 • 12 weeks
|
18.5%
5/27 • Number of events 11 • 12 weeks
|
20.7%
6/29 • Number of events 15 • 12 weeks
|
35.7%
10/28 • Number of events 29 • 12 weeks
|
|
General disorders
Constitutional Symptioms - Nightmares
|
6.7%
2/30 • Number of events 3 • 12 weeks
|
3.7%
1/27 • Number of events 1 • 12 weeks
|
6.9%
2/29 • Number of events 5 • 12 weeks
|
10.7%
3/28 • Number of events 9 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea - without colostomy
|
20.0%
6/30 • Number of events 7 • 12 weeks
|
11.1%
3/27 • Number of events 3 • 12 weeks
|
17.2%
5/29 • Number of events 12 • 12 weeks
|
10.7%
3/28 • Number of events 7 • 12 weeks
|
|
Gastrointestinal disorders
Distension/Bloating, Abdominal
|
20.0%
6/30 • Number of events 11 • 12 weeks
|
25.9%
7/27 • Number of events 14 • 12 weeks
|
34.5%
10/29 • Number of events 15 • 12 weeks
|
21.4%
6/28 • Number of events 12 • 12 weeks
|
|
Ear and labyrinth disorders
Dizziness
|
20.0%
6/30 • Number of events 12 • 12 weeks
|
18.5%
5/27 • Number of events 11 • 12 weeks
|
24.1%
7/29 • Number of events 9 • 12 weeks
|
17.9%
5/28 • Number of events 9 • 12 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
33.3%
10/30 • Number of events 28 • 12 weeks
|
22.2%
6/27 • Number of events 16 • 12 weeks
|
24.1%
7/29 • Number of events 10 • 12 weeks
|
25.0%
7/28 • Number of events 22 • 12 weeks
|
|
Reproductive system and breast disorders
Ejaculatory Dysfunction
|
56.7%
17/30 • Number of events 58 • 12 weeks
|
40.7%
11/27 • Number of events 36 • 12 weeks
|
44.8%
13/29 • Number of events 39 • 12 weeks
|
42.9%
12/28 • Number of events 36 • 12 weeks
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
56.7%
17/30 • Number of events 62 • 12 weeks
|
44.4%
12/27 • Number of events 42 • 12 weeks
|
44.8%
13/29 • Number of events 37 • 12 weeks
|
42.9%
12/28 • Number of events 32 • 12 weeks
|
|
General disorders
Fatigue
|
60.0%
18/30 • Number of events 47 • 12 weeks
|
40.7%
11/27 • Number of events 36 • 12 weeks
|
62.1%
18/29 • Number of events 35 • 12 weeks
|
53.6%
15/28 • Number of events 36 • 12 weeks
|
|
Gastrointestinal disorders
Flatulence
|
36.7%
11/30 • Number of events 22 • 12 weeks
|
33.3%
9/27 • Number of events 21 • 12 weeks
|
31.0%
9/29 • Number of events 17 • 12 weeks
|
39.3%
11/28 • Number of events 27 • 12 weeks
|
|
Vascular disorders
Hypertension
|
13.3%
4/30 • Number of events 8 • 12 weeks
|
29.6%
8/27 • Number of events 17 • 12 weeks
|
13.8%
4/29 • Number of events 8 • 12 weeks
|
10.7%
3/28 • Number of events 8 • 12 weeks
|
|
General disorders
Insomnia
|
50.0%
15/30 • Number of events 45 • 12 weeks
|
29.6%
8/27 • Number of events 20 • 12 weeks
|
37.9%
11/29 • Number of events 26 • 12 weeks
|
39.3%
11/28 • Number of events 26 • 12 weeks
|
|
Psychiatric disorders
Mood Alteration - Agitation
|
10.0%
3/30 • Number of events 5 • 12 weeks
|
18.5%
5/27 • Number of events 10 • 12 weeks
|
24.1%
7/29 • Number of events 10 • 12 weeks
|
28.6%
8/28 • Number of events 12 • 12 weeks
|
|
Psychiatric disorders
Mood Alteration - Anxiety
|
10.0%
3/30 • Number of events 10 • 12 weeks
|
14.8%
4/27 • Number of events 10 • 12 weeks
|
20.7%
6/29 • Number of events 11 • 12 weeks
|
10.7%
3/28 • Number of events 6 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
20.0%
6/30 • Number of events 9 • 12 weeks
|
11.1%
3/27 • Number of events 8 • 12 weeks
|
17.2%
5/29 • Number of events 6 • 12 weeks
|
28.6%
8/28 • Number of events 15 • 12 weeks
|
|
Nervous system disorders
Neurology - Nervousness
|
10.0%
3/30 • Number of events 6 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
3.4%
1/29 • Number of events 1 • 12 weeks
|
10.7%
3/28 • Number of events 7 • 12 weeks
|
|
Nervous system disorders
Neuropathy - Sensory
|
6.7%
2/30 • Number of events 7 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
3.4%
1/29 • Number of events 1 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
General disorders
Pain - Other
|
50.0%
15/30 • Number of events 38 • 12 weeks
|
48.1%
13/27 • Number of events 43 • 12 weeks
|
37.9%
11/29 • Number of events 32 • 12 weeks
|
28.6%
8/28 • Number of events 19 • 12 weeks
|
|
General disorders
Pain - Back
|
0.00%
0/30 • 12 weeks
|
3.7%
1/27 • Number of events 4 • 12 weeks
|
6.9%
2/29 • Number of events 2 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
General disorders
Pain - Extremity - Limb
|
0.00%
0/30 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
7.1%
2/28 • Number of events 2 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain - joint
|
6.7%
2/30 • Number of events 4 • 12 weeks
|
3.7%
1/27 • Number of events 1 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
7.1%
2/28 • Number of events 3 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura - hemorrhage/bleeding into skin or mucosa
|
3.3%
1/30 • Number of events 4 • 12 weeks
|
7.4%
2/27 • Number of events 6 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
3.6%
1/28 • Number of events 3 • 12 weeks
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
0.00%
0/30 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
6.9%
2/29 • Number of events 5 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
|
Psychiatric disorders
Somnolence
|
0.00%
0/30 • 12 weeks
|
3.7%
1/27 • Number of events 1 • 12 weeks
|
3.4%
1/29 • Number of events 1 • 12 weeks
|
14.3%
4/28 • Number of events 7 • 12 weeks
|
|
General disorders
Sweating - Diaphoresis
|
66.7%
20/30 • Number of events 61 • 12 weeks
|
74.1%
20/27 • Number of events 64 • 12 weeks
|
82.8%
24/29 • Number of events 63 • 12 weeks
|
89.3%
25/28 • Number of events 74 • 12 weeks
|
|
Renal and urinary disorders
Urinary Frequency/Urgency
|
6.7%
2/30 • Number of events 5 • 12 weeks
|
3.7%
1/27 • Number of events 4 • 12 weeks
|
6.9%
2/29 • Number of events 5 • 12 weeks
|
10.7%
3/28 • Number of events 8 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • Number of events 3 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
0.00%
0/29 • 12 weeks
|
0.00%
0/28 • 12 weeks
|
Additional Information
Dr. Doug Case
Wake Forest University School of Medicine
Phone: (336) 716-5425
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place