Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

7

Study ID:

NCT01744821

Recruitment Status:

Terminated

Sponsor:

Northwestern University

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There are 2 Locations for this study

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Northwestern University
Chicago Illinois, 60611, United States
NorthShore University HealthSystem
Evanston Illinois, 60201, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

7

Study ID:

NCT01744821

Recruitment Status:

Terminated

Sponsor:


Northwestern University

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