Clinical trial NCT01744821: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Keywords: High Risk
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-12-07
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention
timeFrame: Up to 24 months
measure: Other Surrogate Endpoint Biomarkers Markers of Cancer Prevention
timeFrame: Up to 24 months
Secondary outcomes:
measure: Review of Standard Pathologic Evaluation With Specific Attention to Histologic Markers
timeFrame: Up to 24 months
measure: Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
References: