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

Ovarian Cancer Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01744821
• Other study ID #: STU00064898
• Status: Terminated
• Phase: N/A
• First received: November 30, 2012
• Last updated: July 1, 2015
• Start date: October 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cancer

Intervention

Dietary Supplement:
• Arm A: Vitamin D3 Group

• Placebo

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	NorthShore University HealthSystem	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 24 months	No
Primary	Other Surrogate Endpoint Biomarkers Markers of Cancer Prevention	Decrease in cellular proliferation measured by immunohistochemistry staining with KI67	Up to 24 months	No
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	Up to 24 months	No
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	Up to 24 months	Yes