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Vitamin D, Leptin, Vitamin D Receptor Polymorphism, and Treatment-Related Morbidity in Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03028519
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
This study will evaluate serum vitamin D (25(OH)D) and serum leptin levels at the time of diagnosis of ovarian, primary peritoneal, and/or fallopian tube cancer as well as vitamin D receptor mutation status (FokI SNP genotype). The study will evaluate the impact of vitamin D repletion on serum vitamin D levels, serum leptin levels, and treatment-related morbidity in these patients.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Vitamin D3 Not Applicable

Detailed Description:

This study will contain 2 cohorts: those with normal serum 25(OH)D and those with low serum 25(OH)D at enrollment. The study will take place in women with ovarian, primary peritoneal, and fallopian tube cancer.

Patients who have given written consent to enroll in the study will have a serum 25(OH)D levels, serum leptin levels, and vitamin D receptor FokI single nucleotide polymorphism analyzed at the time of diagnosis. Patients with vitamin D deficiency will be prescribed vitamin D supplementation according to current guidelines. Treatment with cholecalciferol will not impact cancer therapy. Participants treatment course information will be collected prospectively, but will not be dictated by this study. Serum 25(OH)D and leptin levels will be collected again at the completion of primary therapy, 6 months after the completion of primary therapy, and at the time of disease recurrence. If patients remain vitamin D deficient at any of these follow-up time points, they will be referred to an endocrinologist for further work-up and treatment of their vitamin D deficiency. Data collection will continue for up to 1 year after enrollment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin D, Leptin, Vitamin D Receptor Polymorphism, and Treatment-Related Morbidity in Ovarian Cancer
Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Experimental: Treatment
Vitamin D levels will be measured at the time of routine blood work. If Vitamin D levels are found to be low, patients will take 50,000 IU of vitamin D3 weekly daily as maintenance therapy. There is no prospective control arm.
Drug: Vitamin D3



Primary Outcome Measures :
  1. Treatment Related Morbidity [ Time Frame: 1 year ]
    Chemotherapy and 30-day post-operative surgical morbidity will be measured and reported in aggregate as number of patients with chemotherapy-related and/or surgery-related morbidity.


Secondary Outcome Measures :
  1. Survival [ Time Frame: 1 year ]
    disease free survival

  2. Identify serum 25(OH)D and serum leptin relationship [ Time Frame: baseline, at completion of primary cancer therapy, at 6 months post-completion of primary therapy, at recurrence or at 1 year post-completion of primary therapy ]
    Change in serum 25(OH)D levels with vitamin D repletion

  3. Evaluate serum level changes [ Time Frame: baseline, at completion of primary therapy, at 6 months post-completion of primary therapy, at recurrence or at 1 year post-completion of primary therapy] ]
    Change in serum Leptin levels with vitamin D repletion

  4. Mutation Status [ Time Frame: at time of enrollment ]
    Vitamin D Receptor FokI Single Nucleotide Polymorphism mutation status



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a histologic diagnosis of ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology, paracentesis, or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.
  • Patients must have adequate: Renal function: Glomerular Filtration Rate (GFR) > 30; Gastrointestinal absorption: No underlying malabsorption syndrome (i.e. inflammatory bowel disease, celiac disease)
  • Ability to tolerate oral medication
  • Patients taking vitamin D at the time of enrollment without a diagnosis of vitamin D deficiency
  • Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception.
  • If applicable, patients must discontinue breastfeeding prior to study entry.
  • Patients must be at least 18 years old

Exclusion Criteria:

  • Patients with a known pre-existing diagnosis of vitamin D deficiency.
  • Patients with renal disease and a GFR <30
  • Patients with primary hyperparathyroidism
  • Patients with other invasive malignancies, with the exception of nonmelanoma skin cancer.
  • Patients with concomitant endometrial cancer diagnosed at the time of their ovarian cancer are allowed to participate if the endometrial cancer is International Federation of Gynecology and Obstetrics stage 1B or less.
  • Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028519


Contacts
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Contact: Ingrid Block, RN 405 271-8777 ingrid-block@ouhsc.edu

Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Ingrid Block, RN, MS    405-271-8777 ext 48160    ingrid-block@ouhsc.edu   
Contact: Andrea A Andrews, BA    405-271-8777 ext 47848    andrea-andrews@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Laura Holman, MD University of Oklahoma

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03028519     History of Changes
Other Study ID Numbers: 7488
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents