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

Sunnybrook Health Sciences Centre

Status and phase: Completed; Phase 4

Conditions: Anemia; Uterine Cancer; Ovarian Cancer; Cervical Cancer

Treatments: Other: Placebo; Other: Oral Ferrous Fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT01953107

GYNEOCC2

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Ferrous Fumarate 300 mg + Vitamin C

Experimental group

Description:

300 mg once a day of Oral Ferrous Fumarate

Treatment:

Other: Oral Ferrous Fumarate

Placebo + Vitamin C

Placebo Comparator group

Description:

300 mg of Placebo

Treatment:

Other: Placebo