Vitamin D for Women at Increased Risk of Developing Ovarian, Fallopian, or Primary Peritoneal Cancer
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.
Fallopian Tube Cancer
Primary Peritoneal Cancer
Dietary Supplement: Arm A: Vitamin D3 Group
Dietary Supplement: Placebo
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||A Randomized Controlled Pilot Trial of Vitamin D3 Replacement of Placebo Followed by Bilateral Salpingo-Oophorectomy for Women at Increased Risk of Developing Ovarian, Fallopian, or Primary Peritoneal Cancer.|
- The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]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.
- Other Surrogate Endpoint Biomarkers Markers of Cancer Prevention [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]Decrease in cellular proliferation measured by immunohistochemistry staining with KI67
- Review of Standard Pathologic Evaluation With Specific Attention to Histologic Markers [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
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
- Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement. [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]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
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||April 2015|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Arm A: Vitamin D3 Group
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.
|Dietary Supplement: Arm A: Vitamin D3 Group|
Placebo Comparator: Arm B: Placebo Group
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.
|Dietary Supplement: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744821
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|NorthShore University HealthSystem|
|Evanston, Illinois, United States, 60201|