Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer Breast Cancer Folic Acid Deficiency | Drug: Folic Acid Tablet | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study of Serum Folate Levels in Patients Treated With Olaparib |
Actual Study Start Date : | July 21, 2020 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | March 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Folic Acid
Folic Acid supplement 1 mg by mouth daily
|
Drug: Folic Acid Tablet
Folic Acid 1 mg by mouth daily
|
No Intervention: No Supplementation |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lois Winkelman, RN | 312-942-2417 | Lois_Winkelman@rush.edu |
United States, Illinois | |
Rush University Medical Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Lois Winkelman, RN 312-942-2417 |
Tracking Information | |||||||
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First Submitted Date ICMJE | July 10, 2019 | ||||||
First Posted Date ICMJE | July 18, 2019 | ||||||
Last Update Posted Date | July 24, 2020 | ||||||
Actual Study Start Date ICMJE | July 21, 2020 | ||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
|
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
|
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study of Serum Folate Levels in Patients Treated With Olaparib | ||||||
Official Title ICMJE | A Study of Serum Folate Levels in Patients Treated With Olaparib | ||||||
Brief Summary | This is a study investigating folate deficiency (lack of folic acid in the blood) in patients who take the drug olaparib to treat their advanced ovarian or breast cancer. The primary goal of this study is to determine the frequency and timing of folate deficiency, and to learn more about whether giving folic acid supplements (vitamins) will help delay or avoid deficiency in these patients. Deficiency can cause doctors to reduce or stop treatment with olaparib. In this case, patients are not getting the best treatment for their cancer due to the unwanted side effect. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 Phase 3 |
||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
|
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Intervention ICMJE | Drug: Folic Acid Tablet
Folic Acid 1 mg by mouth daily
|
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
75 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | March 2022 | ||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
|
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
|
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04024254 | ||||||
Other Study ID Numbers ICMJE | 18070604 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Lydia Usha, Rush University Medical Center | ||||||
Study Sponsor ICMJE | Rush University Medical Center | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Rush University Medical Center | ||||||
Verification Date | July 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |