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

NCT01744821 | Terminated Results

• 1 other identifier: STU00064898
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Keywords

High Risk

Outcome Measures

Primary Outcomes (2)

• The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention

  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.

  Up to 24 months

• Other Surrogate Endpoint Biomarkers Markers of Cancer Prevention

  Decrease in cellular proliferation measured by immunohistochemistry staining with KI67

  Up to 24 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Arm A: Vitamin D3 Group

ACTIVE COMPARATOR

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.

Dietary Supplement: Arm A: Vitamin D3 Group

Arm B: Placebo Group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Arm A: Vitamin D3 Group DIETARY_SUPPLEMENT

Arm A: Vitamin D3 Group

Placebo DIETARY_SUPPLEMENT

Arm B: Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Limitations and Caveats

Low accrual led to this pilot study closing early. Accrual barriers included the 4-week minimum treatment time frame and narrow eligibility criteria. Small numbers prohibit meaningful analysis. Study provides important insights to recruitment.

Results Point of Contact

• Title: Assistant Professor
• Organization: Northwestern University

dcarson@nm.org

312-472-4684

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 7, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2015
• Last Updated: July 23, 2015
• Results First Posted: March 23, 2015

Record last verified: 2015-07

Locations

US (2)