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
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Vitamin D3||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- Survival [ Time Frame: 1 year ]disease free survival
- 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
- 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
- Mutation Status [ Time Frame: at time of enrollment ]Vitamin D Receptor FokI Single Nucleotide Polymorphism mutation status
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
|Contact: Ingrid Block, RN||405 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Andrea A Andrews, BA 405-271-8777 ext 47848 firstname.lastname@example.org|
|Principal Investigator:||Laura Holman, MD||University of Oklahoma|