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.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
结局指标
主要结局
The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention
时间窗: Up to 24 months
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.
Other Surrogate Endpoint Biomarkers Markers of Cancer Prevention
时间窗: Up to 24 months
Decrease in cellular proliferation measured by immunohistochemistry staining with KI67
次要结局
- Review of Standard Pathologic Evaluation With Specific Attention to Histologic Markers(Up to 24 months)
- Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.(Up to 24 months)