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Inability to recruit study subjects
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The purpose of this research is to study Vitamin D3 replacement for patients at high risk of developing ovarian, fallopian tube, or peritoneal cancer, and see if the Vitamin D3 replacement may be able to prevent the cancer.
This study is being done because in the United States ovarian cancer is the leading cause of death among women with gynecologic cancer. Women with BRCA mutations, a personal history of breast cancer, and a family history of breast and ovarian cancer are at high risk of developing ovarian, fallopian, and primary peritoneal cancer. Novel treatments other than surgery which can decrease the risk of developing ovarian, fallopian tube, and primary peritoneal cancer are important. Vitamin D has been shown to reduce the risk of developing bladder, breast, colon, endometrial, esophageal, gallbladder, gastric, lung, pancreatic, prostate, rectal, renal, vulvar and Hodgkin and non-Hodgkin lymphoma, and it may play a role in the prevention of ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Vitamin D3 Group | Active Comparator | Patients will take Vitamin D3 by mouth in the weeks prior to and including the morning of surgery. If blood test done at the start of the study shows that patients have a low (< or = 30 ng/ml) Vitamin D level, patients will be given two 25,000 IU Vitamin D3 Tablets (for a total of 50,000 IU) to take once a week until surgery. If baseline Vitamin D level is >30ng/ml, patients will be given on 2,000 IU Vitamin D3 tablet to take once a day until day of surgery. |
|
| Arm B: Placebo Group | Placebo Comparator | Patients will take a placebo by mouth prior to and including the morning of surgery. If bloods tests done at the start of study show that the patients have a low (< or = 30 ng/ml) Vitamin D level, patients will be given 2 placebo tablets to take once a week until surgery. If baseline Vitamin D level is > 30 ng/ml, patients will be given on placebo tablet to take once a day until surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm A: Vitamin D3 Group | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention | Activation of apoptosis via immunohistochemical measurement of activation of caspase activity, as well as expression of BAX and BCL-2 The primary marker outcomes will be assessed for normality and compared between groups using a two-sample t-test or a Wilcoxon rank sum test. Other markers will be compared similarly if continuous, or by Fisher's exact test if categorical. | Up to 24 months |
| Other Surrogate Endpoint Biomarkers Markers of Cancer Prevention | Decrease in cellular proliferation measured by immunohistochemistry staining with KI67 | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Review of Standard Pathologic Evaluation With Specific Attention to Histologic Markers | The outcomes that will be measured for the secondary objectives of this study will include the following: Review of standard pathologic evaluation with specific attention to histologic markers including serous hyperplasia, tubal atypia, and p53 signature in the ovary and fallopian tube, and examine via immunohistochemistry the effects of vitamin D supplementation on expression of the TGF-beta isoforms and CYP24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| NorthShore University HealthSystem |
Baseline evaluation included physical examination, personal and family history questionnaire, and blood test including serum 25(OH)D. Based on vitamin D level, subjects were randomized to 1 of 4 groups.
Eligible participants were women at high risk for ovarian cancer and undergoing a prophylactic salpingo-oophorectomy. Subjects were recruited in the outpatient gynecologic oncology clinics of the study investigators. The study opened 6/1/12 with a goal of 80 subjects. It closed on 1/12/15 with a total of 7 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D 50,000 IU Weekly | If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks) |
| FG001 | Placebo 50,000 IU Weekly | If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks) |
| FG002 | Vitamin D 2,000 IU Daily | If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week) |
| FG003 | Placebo 2,000 IU Daily | If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
With a total of 80 patients (40 per arm), assuming a Type I error rate of 5% and a power of 80, an effect size of 0.63 may be detected between patients exposed to Vitamin D supplementation and those not exposed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D 50,000 IU Weekly | If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks) |
| BG001 | Placebo 50,000 IU Weekly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention | Activation of apoptosis via immunohistochemical measurement of activation of caspase activity, as well as expression of BAX and BCL-2 The primary marker outcomes will be assessed for normality and compared between groups using a two-sample t-test or a Wilcoxon rank sum test. Other markers will be compared similarly if continuous, or by Fisher's exact test if categorical. | We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers. | Posted | Up to 24 months |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D 50,000 IU Weekly | If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
Low accrual led to this pilot study closing early. Accrual barriers included the 4-week minimum treatment time frame and narrow eligibility criteria. Small numbers prohibit meaningful analysis. Study provides important insights to recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Professor | Northwestern University | 312-472-4684 | dcarson@nm.org |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Dietary Supplement |
|
| Up to 24 months |
| Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement. | Differences in the types and incidence of toxicities associated with Vitamin D3 replacement, specifically hypercalcemia, with increasing levels of Vitamin D3 along with the effectiveness of Vitamin D3 supplementation on increasing serum levels of Vitamin D | Up to 24 months |
| Evanston |
| Illinois |
| 60201 |
| United States |
If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
| BG002 | Vitamin D 2,000 IU Daily | If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week) |
| BG003 | Placebo 2,000 IU Daily | If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks) |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo 50,000 IU Weekly | If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks) |
| OG002 | Vitamin D 2,000 IU Daily | If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week) |
| OG003 | Placebo 2,000 IU Daily | If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks) |
|
| Primary | Other Surrogate Endpoint Biomarkers Markers of Cancer Prevention | Decrease in cellular proliferation measured by immunohistochemistry staining with KI67 | We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers. | Posted | Up to 24 months |
|
|
| Secondary | Review of Standard Pathologic Evaluation With Specific Attention to Histologic Markers | The outcomes that will be measured for the secondary objectives of this study will include the following: Review of standard pathologic evaluation with specific attention to histologic markers including serous hyperplasia, tubal atypia, and p53 signature in the ovary and fallopian tube, and examine via immunohistochemistry the effects of vitamin D supplementation on expression of the TGF-beta isoforms and CYP24 | We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers. | Posted | Up to 24 months |
|
|
| Secondary | Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement. | Differences in the types and incidence of toxicities associated with Vitamin D3 replacement, specifically hypercalcemia, with increasing levels of Vitamin D3 along with the effectiveness of Vitamin D3 supplementation on increasing serum levels of Vitamin D | Posted | Number | participants | Up to 24 months |
|
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Placebo 50,000 IU Weekly | If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks) | 0 | 3 | 1 | 3 |
| EG002 | Vitamin D 2,000 IU Daily | If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week) | 0 | 2 | 2 | 2 |
| EG003 | Placebo 2,000 IU Daily | If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks) | 0 | 1 | 0 | 1 |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| Dry Mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
| Weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Grade1 |
|
| Loss of Appetite | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Grade 1 |
|
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| Headache grade 1 |
|
| Hypercalcemia |
|
| Loss of Appetite grade 1 |
|
| Dry Mouth grade 1 |
|
| Constipation grade 1 |
|
| Weakness grade 1 |
|