Oral Iron vs. Placebo in Newly Diagnosed Gynecologic Oncology Patients Who Are Surgical Candidates.
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|ClinicalTrials.gov Identifier: NCT01953107|
Recruitment Status : Active, not recruiting
First Posted : September 30, 2013
Last Update Posted : April 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Cervical Cancer Uterine Cancer Anemia||Other: Oral Ferrous Fumarate Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, 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.|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||December 2018|
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
- Mean Difference in Hemoglobin [ Time Frame: Pre-surgery (4-6 weeks) ]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) ]The difference in quality of life (FACT-An) between patients treated with ferrous fumarate 300 mg. daily to placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953107
|Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Danielle Vicus, MD||Odette Cancer Centre|