Trial Outcomes & Findings for Vitamin D and Soy Supplements in Treating Patients With Recurrent Prostate Cancer (NCT NCT00499408)
NCT ID: NCT00499408
Last Updated: 2018-11-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
up to one year
Results posted on
2018-11-21
Participant Flow
Participant milestones
| Measure |
Vitamin D and Soy Supplementation
oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D and Soy Supplements in Treating Patients With Recurrent Prostate Cancer
Baseline characteristics by cohort
| Measure |
Vitamin D and Soy Supplementation
n=26 Participants
oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
72.4 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to one yearPopulation: Only 23 participants evaluable for a response.
Outcome measures
| Measure |
Vitamin D and Soy Supplementation
n=23 Participants
oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
|
|---|---|
|
Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment
|
0 participants
|
SECONDARY outcome
Timeframe: up to one yearPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to one yearPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to one yearToxicity will be graded according to the revised NCI Common Terminology Criteria for Adverse Events v 3.0, (CTCAE). Number of events with grade 1-5 will be reported.
Outcome measures
| Measure |
Vitamin D and Soy Supplementation
n=26 Participants
oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
|
|---|---|
|
Number of Adverse Events, Grades 1-5
Grade 1
|
93 events
|
|
Number of Adverse Events, Grades 1-5
Grade 2
|
30 events
|
|
Number of Adverse Events, Grades 1-5
Grade 3
|
7 events
|
|
Number of Adverse Events, Grades 1-5
Grade 4
|
0 events
|
|
Number of Adverse Events, Grades 1-5
Grade 5
|
1 events
|
SECONDARY outcome
Timeframe: up to three yearsPopulation: 16 subjects progress out of the 23 evaluable for response.
Progression will be defined as a 50% rise in serum PSA compared to the baseline value confirmed on at least two measurements at least two weeks apart.
Outcome measures
| Measure |
Vitamin D and Soy Supplementation
n=16 Participants
oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
|
|---|---|
|
Time to Progression
|
10.3 months
Interval 4.0 to 35.0
|
Adverse Events
Vitamin D and Soy Supplementation
Serious events: 5 serious events
Other events: 26 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Vitamin D and Soy Supplementation
n=26 participants at risk
oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
|
|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
3.8%
1/26 • Number of events 1 • up to 3 years
|
|
Investigations
hyperglycemia
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
Investigations
hypoglycemia
|
3.8%
1/26 • Number of events 1 • up to 3 years
|
|
Investigations
Partial Thromboplastin Time
|
3.8%
1/26 • Number of events 1 • up to 3 years
|
|
Investigations
Lymphopenia
|
3.8%
1/26 • Number of events 1 • up to 3 years
|
|
General disorders
Syncope (fainting)
|
3.8%
1/26 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Skin Infection with high grade neutropenia
|
3.8%
1/26 • Number of events 1 • up to 3 years
|
Other adverse events
| Measure |
Vitamin D and Soy Supplementation
n=26 participants at risk
oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
|
|---|---|
|
Investigations
Low WBC
|
30.8%
8/26 • Number of events 8 • up to 3 years
|
|
Investigations
low Platelets
|
23.1%
6/26 • Number of events 6 • up to 3 years
|
|
Investigations
Low Hemoglobin
|
53.8%
14/26 • Number of events 14 • up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
15.4%
4/26 • Number of events 4 • up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
General disorders
Anorexia
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
Investigations
Alkaline phosphatase
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
Investigations
Creatinine
|
11.5%
3/26 • Number of events 3 • up to 3 years
|
|
General disorders
"Incontinence, urinary"
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
General disorders
Hypertension
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
General disorders
Taste alteration
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
General disorders
Rigors/chills
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
General disorders
Fatigue
|
26.9%
7/26 • Number of events 7 • up to 3 years
|
|
Investigations
hyperglycemia
|
53.8%
14/26 • Number of events 14 • up to 3 years
|
|
Investigations
hypoglycemia
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
Investigations
hypocalcemia
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
Investigations
hyponatremia
|
15.4%
4/26 • Number of events 4 • up to 3 years
|
|
Investigations
hypoalbuminemia
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
Investigations
hyperbilirubinemia
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
Investigations
hypophosphatemia
|
15.4%
4/26 • Number of events 4 • up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
23.1%
6/26 • Number of events 6 • up to 3 years
|
|
General disorders
Pain: Head/headache
|
11.5%
3/26 • Number of events 3 • up to 3 years
|
|
General disorders
Fever without neutropenia
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
General disorders
Erectile dysfunction
|
11.5%
3/26 • Number of events 3 • up to 3 years
|
|
General disorders
Urinary frequency/urgency
|
53.8%
14/26 • Number of events 14 • up to 3 years
|
|
General disorders
Renal/Genitourinary - Other
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
Vascular disorders
Edema: limb
|
11.5%
3/26 • Number of events 3 • up to 3 years
|
|
General disorders
Dry mouth
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
General disorders
Pain: Abdomen
|
15.4%
4/26 • Number of events 4 • up to 3 years
|
|
General disorders
Pain: Joint
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
General disorders
Arthritis (non-septic)
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
General disorders
Pain: Back
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
Gastrointestinal disorders
Flatulence
|
15.4%
4/26 • Number of events 4 • up to 3 years
|
|
Investigations
Glomerular filtration rate
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
Investigations
"Cholesterol, serum-high"
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
General disorders
Libido
|
30.8%
8/26 • Number of events 8 • up to 3 years
|
|
Investigations
Lymphopenia
|
19.2%
5/26 • Number of events 5 • up to 3 years
|
|
General disorders
Pain: Muscle
|
23.1%
6/26 • Number of events 6 • up to 3 years
|
|
General disorders
Pain: Extremity-limb
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
Allergic rhinitis
|
42.3%
11/26 • Number of events 11 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
"Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower"
|
7.7%
2/26 • Number of events 2 • up to 3 years
|
Additional Information
K.C. Balaji, MD
Comprehensive Cancer Center of Wake Forest University
Phone: 336-716-5690
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place