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

Northwestern University

Status: Terminated

Conditions: Primary Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Arm A: Vitamin D3 Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01744821

STU00064898

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

7 participants in 2 patient groups, including a placebo group

Arm A: Vitamin D3 Group

Active Comparator 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.

Treatment:

Dietary Supplement: Arm A: Vitamin D3 Group

Arm B: Placebo Group

Placebo Comparator group

Description:

Patients will take a placebo by mouth prior to and including the morning of surgery. If bloods tests done at the start of study show that the patients have a low (\< or = 30 ng/ml) Vitamin D level, patients will be given 2 placebo tablets to take once a week until surgery. If baseline Vitamin D level is \> 30 ng/ml, patients will be given on placebo tablet to take once a day until surgery.

Treatment:

Dietary Supplement: Placebo