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

NCT03028519 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 7488
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (4)

• Survival

  1 year

• Identify serum 25(OH)D and serum leptin relationship

  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

• Evaluate serum level changes

  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]

• Mutation Status

  at time of enrollment

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

Vitamin D3 DRUG

Vitamin D3

Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Cholecalciferol

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Laura Holman, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 23, 2017
• Study Start: January 31, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)