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The prevalence of anemia in gynecologic oncology new patients has been seen in previous studies to be as high as 35-59%. this population includes women with several types of gynecologic malignancies. Therefore, it is assumed that the origin of the anemia can be due to anemia of chronic disease and iron deficiency anemia. No previous studies have looked at the efficacy of oral iron supplementation with concurrent Vitamin C in women with newly diagnosed gynecologic malignancies.
Hypothesis: In newly diagnosed gynecologic oncology patients who are surgical candidates does treatment with 3-6 weeks of oral ferrous fumarate 300 mg once a day improve the mean change in hemoglobin levels, from baseline to pre-operative, in comparison to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferrous Fumarate 300 mg + Vitamin C | Experimental | 300 mg once a day of Oral Ferrous Fumarate |
|
| Placebo + Vitamin C | Placebo Comparator | 300 mg of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Ferrous Fumarate | Other |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Hemoglobin | The mean difference in the change of hemoglobin levels from baseline to the day of surgery between participants treated with oral iron versus. placebo. | Pre-surgery (4-6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | The difference in quality of life (FACT-An) between patients treated with ferrous fumarate 300 mg. daily to placebo. | Baseline to Pre-surgery (4-6 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle Vicus, MD | Odette Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D014594 | Uterine Neoplasms |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C031621 | ferrous fumarate |
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|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |