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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.


N/A
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The outcomes that will be measured for the primary objectives of this study will be surrogate endpoint biomarkers markers of cancer prevention

Outcome Description:

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.

Outcome Time Frame:

Up to 24 months

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

STU00064898

NCT ID:

NCT01744821

Start Date:

October 2012

Completion Date:

October 2016

Related Keywords:

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

Name

Location

Northwestern UniversityChicago, Illinois  60611