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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Treatment Related Morbidity
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

Survival
disease free survival
Identify serum 25(OH)D and serum leptin relationship
Change in serum 25(OH)D levels with vitamin D repletion
Evaluate serum level changes
Change in serum Leptin levels with vitamin D repletion
Mutation Status
Vitamin D Receptor FokI Single Nucleotide Polymorphism mutation status

Full Information

First Posted
January 10, 2017
Last Updated
April 11, 2022
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT03028519
Brief Title
Vitamin D, Leptin, Vitamin D Receptor Polymorphism, and Treatment-Related Morbidity in Ovarian Cancer
Official Title
Vitamin D, Leptin, Vitamin D Receptor Polymorphism, and Treatment-Related Morbidity in Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Intervention Description
Vitamin D3
Primary Outcome Measure Information:
Title
Treatment Related Morbidity
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Survival
Description
disease free survival
Time Frame
1 year
Title
Identify serum 25(OH)D and serum leptin relationship
Description
Change in serum 25(OH)D levels with vitamin D repletion
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
Title
Evaluate serum level changes
Description
Change in serum Leptin levels with vitamin D repletion
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]
Title
Mutation Status
Description
Vitamin D Receptor FokI Single Nucleotide Polymorphism mutation status
Time Frame
at time of enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Holman, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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