Oral Iron vs. Placebo in Newly Diagnosed Gynecologic Oncology Patients Who Are Surgical Candidates.

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of Pre-Operative Treatment With Ferrous Fumarate 300 mg Once Daily Versus Placebo in Newly Diagnoses Gynecologic Oncology Patients Who Are Primary Surgical Candidates.

Conditions
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Ovarian Cancer, Cervical Cancer, Uterine Cancer, Anemia

Intervention / Treatment
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* Other: Oral Ferrous Fumarate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over the age of 18 Scheduled for primary operative procedure within 3-6 weeks of initial consult clinic visit with endometrial cancer, uterine sarcoma, cervical cancer, ovarian/fallopian tube cancer or patients with pelvic mass and a high suspicion of a gynecologic malignancy. Exclusion Criteria: Patient with known allergy to ferrous fumarate. Patient's on IV Iron or erythropoietin treatment at the time of recruitment Patient's who are not primary surgical candidates. Patient's with a known hemoglobinopathy or a hypoproliferative hematologic disorder Patient who have significant active vaginal bleeding Patient who have a hemoglobin < 80 g/L will be removed from randomization and referred to blood conservation at Sunnybrook Health SCiences Centre.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferrous Fumarate 300 mg + Vitamin C<br>300 mg once a day of Oral Ferrous Fumarate | Other: Oral Ferrous Fumarate<br> <br> |
| Placebo Comparator: Placebo + Vitamin C<br>300 mg of Placebo | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Ovarian cancer, Uterine cancer, Cervical cancer, Oral iron