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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2020-12-31

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.

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Detailed Description

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Conditions

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Ovarian Cancer Cervical Cancer Uterine Cancer Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ferrous Fumarate 300 mg + Vitamin C

300 mg once a day of Oral Ferrous Fumarate

Group Type EXPERIMENTAL

Oral Ferrous Fumarate

Intervention Type OTHER

Placebo + Vitamin C

300 mg of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Oral Ferrous Fumarate

Intervention Type OTHER

Placebo

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No