Oral Iron vs. Placebo in Newly Diagnosed Gynecologic Oncology Patients Who Are Surgical Candidates.
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.
Other: Oral Ferrous Fumarate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
|Official Title:||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.|
- Mean Difference in Hemoglobin [ Time Frame: Pre-surgery (4-6 weeks) ] [ Designated as safety issue: No ]The mean difference in the change of hemoglobin levels from baseline to the day of surgery between participants treated with oral iron versus. placebo.
- Quality of life [ Time Frame: Baseline to Pre-surgery (4-6 weeks) ] [ Designated as safety issue: No ]The difference in quality of life (FACT-An) between patients treated with ferrous fumarate 300 mg. daily to placebo.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Ferrous Fumarate 300 mg + Vitamin C
300 mg once a day of Oral Ferrous Fumarate
|Other: Oral Ferrous Fumarate|
Placebo Comparator: Placebo + Vitamin C
300 mg of Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01953107
|Contact: Jessica Marer, Clinical Research Associate||416-480-5000 ext firstname.lastname@example.org|
|Odette Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator: Dr. Danielle Vicus, MD|
|Principal Investigator:||Danielle Vicus, MD||Odette Cancer Centre|