Vitamin D for Women at Increased Risk of Developing Ovarian, Fallopian, or Primary Peritoneal Cancer

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

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

, ,

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