Anemia, Cervical Cancer, Ovarian Cancer, Uterine Cancer
Conditions
Keywords
Anemia, Ovarian cancer, Uterine cancer, Cervical cancer, Oral iron
Brief summary
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.
Interventions
OTHERPlacebo
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Hemoglobin | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 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. |
Countries
Canada
Outcome results
None listed