Condition or disease | Intervention/treatment | Phase |
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Epithelial Ovarian Cancer Anemia Iron Deficiency Anemia | Other: Iron Sucrose | Phase 1 Phase 2 |
Iron deficiency and anemia are common in cancer patients. Data from the University of Wisconsin (UW) suggest that more than 50% of ovarian cancer patients undergo blood transfusion during their cancer treatments. Transfusion rates are particularly high in patients who receive neoadjuvant chemotherapy (NACT), despite multiple opportunities to diagnose and treat anemia prior to surgery. Blood transfusions have been associated with worse survival in ovarian cancer patients. Seventy-seven percent of ovarian cancer patients who receive NACT at the UW are anemic prior to surgery, and the same percentage receive a perioperative blood transfusion, defined as a blood transfusion within 72 hours of surgery. Iron deficiency without anemia is also common in cancer patients, though little has been published regarding how frequently it occurs in ovarian cancer patients. Functional iron deficiency, a lack of iron incorporation into erythroid precursors despite adequate iron stores, is also common in cancer patients. Study investigators hypothesize that IV iron sucrose infusions given to iron deficient ovarian cancer patients prior to debulking surgery can improve pre-operative iron stores and decrease transfusion of packed red blood cells in the peri-operative period.
Eligible participants will have a new epithelial ovarian cancer diagnosis, with planned neoadjuvant chemotherapy and interval debulking surgery. The study cohort will consist of participants with iron deficiency without anemia (defined below) prior to starting chemotherapy. Iron deficient participants with anemia are already offered iron sucrose infusions as part of their standard of care treatment.
The study group will include participants with planned neoadjuvant chemotherapy and debulking surgery with a normal Hgb within 30 days of study enrollment. Iron studies including ferritin, transferrin, total iron binding capacity (TIBC), reticulocyte count and serum iron, will be performed on these participants for research purposes only. Consent will be obtained prior to drawing research-related iron studies. The majority of participants will have Hgb levels available in their records from the last 30 days, either from the UW, or from a referring institution. If this is not the case, pre-chemotherapy lab studies will be obtained the day of their visit, which would routinely include a Hgb level.
Participants will sign a consent to receive four IV iron sucrose transfusions, prior to their debulking surgery, and be followed for prospective data collection. Consent will be signed for the infusion and for prospective data collection related to future laboratory studies and rates of transfusion of blood products. Participants with a normal Hgb and normal iron studies will participate in the prospective data collection portion of this study only. Prospective data collection will continue until subjects have completed first-line chemotherapy.
Subjects will be enrolled until 21 evaluable participants have been enrolled. Evaluable participants will have true or functional iron deficiency without anemia and have received at least one IV iron sucrose infusion.
Iron studies will be repeated 21 days (+/- 7 days) after last infusion in participants who receive IV iron sucrose. Participants with persistent iron deficiency will be referred to hematology.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Unblinded, window of opportunity trial |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy |
Actual Study Start Date : | July 29, 2019 |
Estimated Primary Completion Date : | January 2022 |
Estimated Study Completion Date : | January 2023 |
Arm | Intervention/treatment |
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Experimental: IV Iron Sucrose
Four intravenous iron sucrose infusions prior to debulking surgery administered as four 200mg infusions, given no less than 7 days apart over a 30 day +/- 7 day period
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Other: Iron Sucrose
Venofer (Iron Sucrose Injection USP) is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use.
Other Name: Venofer
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Iron deficiency anemia is defined as ferritin > 30 ng/mL and iron saturation of < 50%.
This endpoint will be summarized with descriptive statistics and conducted using a Fisher's exact test and exact binomial confidence intervals. In particular, point estimates and exact 95% confidence intervals (CI) will be calculated.
Safety and Tolerability will be monitored by measuring adverse events data with date of onset (or worsening) on or after the start-date treatment with iron sucrose and end of study (post-operative visit (7 to 21 days following surgery). AEs are defined as mild, moderate and severe.
This endpoint will be summarized with descriptive statistics and conducted using a Fisher's exact test and exact binomial confidence intervals. In particular, point estimates and exact 95% confidence intervals (CI) will be calculated.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Has a diagnosis of true or functional iron deficiency without anemia within 30 days of treatment on this protocol
Exclusion Criteria:
Contact: Cancer Connect | 800-622-8922 | clinicaltrials@cancer.wisc.edu |
United States, Wisconsin | |
University of Wisconsin Carbone Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: Cancer Connect 800-622-8922 clinicaltrials@cancer.wisc.edu | |
Principal Investigator: Lisa Barroilhet, MD | |
Sub-Investigator: Joseph Connor, MD | |
Sub-Investigator: Moniba Nazeef, MD | |
Sub-Investigator: Janelle Sobecki-Rausch, MD |
Principal Investigator: | Lisa Barroilhet, MD | University of Wisconsin, Madison |
Tracking Information | |||||
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First Submitted Date ICMJE | April 29, 2019 | ||||
First Posted Date ICMJE | May 1, 2019 | ||||
Last Update Posted Date | December 30, 2020 | ||||
Actual Study Start Date ICMJE | July 29, 2019 | ||||
Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Rate of Peri-operative Blood Transfusion [ Time Frame: Within 72 hours of surgery, up to 5 weeks on study ] Defined as a transfusion of Packed Red Blood Cells (PRBCs) within 72 hours of surgery, in iron deficient ovarian cancer patients who receive IV iron sucrose therapy prior to surgery compared to a historical controls (historically 77%). The primary endpoint will be summarized with descriptive statistics and conducted using a Fisher's exact test and exact binomial confidence intervals. Point estimates and exact 95% confidence intervals (CI) will be calculated.
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Original Primary Outcome Measures ICMJE |
Rate of Peri-operative Blood Transfusion [ Time Frame: Within 72 hours of surgery, up to 5 weeks on study ] Defined as a transfusion of PRBCs within 72 hours of surgery, in iron deficient ovarian cancer patients who receive IV iron sucrose therapy prior to surgery compared to a historical controls (historically 77%). The primary endpoint will be summarized with descriptive statistics and conducted using a Fisher's exact test and exact binomial confidence intervals. Point estimates and exact 95% confidence intervals (CI) will be calculated.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients | ||||
Official Title ICMJE | Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy | ||||
Brief Summary | This study tests the hypothesis that IV iron sucrose infusions given to iron deficient ovarian cancer patients prior to debulking surgery can improve pre-operative iron stores and decrease transfusion of packed red blood cells in the peri-operative period. 21 participants at least 18 years of age with epithelial ovarian cancer of any stage requiring neoadjuvant chemotherapy and surgery will be enrolled. Participants will be on study for a period of up to 3 months. | ||||
Detailed Description |
Iron deficiency and anemia are common in cancer patients. Data from the University of Wisconsin (UW) suggest that more than 50% of ovarian cancer patients undergo blood transfusion during their cancer treatments. Transfusion rates are particularly high in patients who receive neoadjuvant chemotherapy (NACT), despite multiple opportunities to diagnose and treat anemia prior to surgery. Blood transfusions have been associated with worse survival in ovarian cancer patients. Seventy-seven percent of ovarian cancer patients who receive NACT at the UW are anemic prior to surgery, and the same percentage receive a perioperative blood transfusion, defined as a blood transfusion within 72 hours of surgery. Iron deficiency without anemia is also common in cancer patients, though little has been published regarding how frequently it occurs in ovarian cancer patients. Functional iron deficiency, a lack of iron incorporation into erythroid precursors despite adequate iron stores, is also common in cancer patients. Study investigators hypothesize that IV iron sucrose infusions given to iron deficient ovarian cancer patients prior to debulking surgery can improve pre-operative iron stores and decrease transfusion of packed red blood cells in the peri-operative period. Eligible participants will have a new epithelial ovarian cancer diagnosis, with planned neoadjuvant chemotherapy and interval debulking surgery. The study cohort will consist of participants with iron deficiency without anemia (defined below) prior to starting chemotherapy. Iron deficient participants with anemia are already offered iron sucrose infusions as part of their standard of care treatment. The study group will include participants with planned neoadjuvant chemotherapy and debulking surgery with a normal Hgb within 30 days of study enrollment. Iron studies including ferritin, transferrin, total iron binding capacity (TIBC), reticulocyte count and serum iron, will be performed on these participants for research purposes only. Consent will be obtained prior to drawing research-related iron studies. The majority of participants will have Hgb levels available in their records from the last 30 days, either from the UW, or from a referring institution. If this is not the case, pre-chemotherapy lab studies will be obtained the day of their visit, which would routinely include a Hgb level. Participants will sign a consent to receive four IV iron sucrose transfusions, prior to their debulking surgery, and be followed for prospective data collection. Consent will be signed for the infusion and for prospective data collection related to future laboratory studies and rates of transfusion of blood products. Participants with a normal Hgb and normal iron studies will participate in the prospective data collection portion of this study only. Prospective data collection will continue until subjects have completed first-line chemotherapy. Subjects will be enrolled until 21 evaluable participants have been enrolled. Evaluable participants will have true or functional iron deficiency without anemia and have received at least one IV iron sucrose infusion. Iron studies will be repeated 21 days (+/- 7 days) after last infusion in participants who receive IV iron sucrose. Participants with persistent iron deficiency will be referred to hematology. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Unblinded, window of opportunity trial Masking: None (Open Label)Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE | Other: Iron Sucrose
Venofer (Iron Sucrose Injection USP) is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use.
Other Name: Venofer
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Study Arms ICMJE | Experimental: IV Iron Sucrose
Four intravenous iron sucrose infusions prior to debulking surgery administered as four 200mg infusions, given no less than 7 days apart over a 30 day +/- 7 day period
Intervention: Other: Iron Sucrose
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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 |
40 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | January 2023 | ||||
Estimated Primary Completion Date | January 2022 (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 | NCT03933813 | ||||
Other Study ID Numbers ICMJE | UW18106 2019-0022 ( Other Identifier: Institutional Review Board ) A532820 ( Other Identifier: UW Madison ) SMPH/OB-GYN/GYN ONCOLOGY ( Other Identifier: UW Madison ) NCI-2019-02185 ( Registry Identifier: NCI Trial ID ) Protocol Version 8/15/2019 ( Other Identifier: UW Madison ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Wisconsin, Madison | ||||
Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University of Wisconsin, Madison | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |