Oral Iron vs. Placebo in Newly Diagnosed Gynecologic Oncology Patients Who Are Surgical Candidates.
Ovarian Cancer - Cervical Cancer - Uterine Cancer - Anemia
Conditions: official terms
Ovarian Neoplasms - Uterine Cervical Neoplasms - Uterine Neoplasms
Conditions: Keywords
Anemia, Ovarian cancer, Uterine cancer, Cervical cancer, Oral iron
Study Type
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Name: Oral Ferrous Fumarate Type: Other
Name: Placebo Type: Other
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Male
Criteria: 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.
Odette Cancer Centre
Toronto, Ontario, Canada
Status: Recruiting
Start Date
November 2013
Completion Date
November 2016
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page