Brief Title
Vitamin D for Women at Increased Risk of Developing Ovarian, Fallopian, or Primary Peritoneal Cancer
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.
Brief Summary
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.
Study Type
Interventional
Primary Outcome
The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention
Secondary Outcome
Review of Standard Pathologic Evaluation With Specific Attention to Histologic Markers
Condition
Ovarian Cancer
Intervention
Arm A: Vitamin D3 Group
Study Arms / Comparison Groups
Arm A: Vitamin D3 Group
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
7
Start Date
October 2012
Completion Date
April 2015
Primary Completion Date
April 2014
Eligibility Criteria
Inclusion Criteria:
- Patients must be undergoing prophylactic or therapeutic oophorectomy
- Patients must be considered to be at a high risk of developing ovarian, fallopian or
primary peritoneal cancer, according to 1 or more of the following characteristics:
- Patients with a BRCA mutation including variants of uncertain significance
- Patients with Lynch syndrome
- Patients with a family history that places them at high risk of developing ovarian
cancer
- Patients with a personal history of breast cancer
- Patients currently taking Vitamin D prior to registration will be eligible if serum
Vitamin D levels are <60ng/ml. We believe that most of these patients will be on low
replacement doses of Vitamin D3 to begin with but in order to prevent against toxicity
their Vitamin D3 levels will be checked at the start of the trial.
- Patients must be women age 18 and older
- Patients who are of childbearing potential and sexually active must use contraception
while on study.
- Patients must have a signed and witnessed informed consent and authorization
permitting release of personal health information prior to registration on the study.
Exclusion Criteria:
- Patients who are unable to take Vitamin D3 supplementation are NOT eligible
- Patients who are unwilling or unable to undergo oophorectomy are NOT eligible
- Patients with suspicious or abnormal findings on preoperative physical exam,
laboratory results, or imaging studies within 4 weeks of treatment start are NOT
eligible
- Patients with a GFR <59 within 4 weeks of treatment start are NOT eligible
- Patients are NOT eligible if they exhibit any contraindications within 4 weeks of
treatment start to 25 (OH) D supplement including:
- Hypercalcemia (>11.5mg/dL)
- Hypervitaminosis D
- Malabsorption syndrome
- Active gallbladder disease
- Active hepatic disease
- Hypoparathyroidism
- Leukemia
- Nephrolithiasis
- Renal failure sarcoidosis
- Renal disease (eGFR<59 ml/min/1.73m2)
- Patients currently receiving digoxin are NOT eligible
- Patients who are pregnant or breastfeeding are NOT eligible. Patients must have a
negative urine pregnancy test at baseline (within 4 weeks of treatment start) to
confirm eligibility
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01744821
Organization ID
STU00064898
Responsible Party
Sponsor
Study Sponsor
Northwestern University
Study Sponsor
, ,
Verification Date
July 2015