Oral Iron vs. Placebo in Newly Diagnosed Gynecologic Oncology Patients Who Are Surgical Candidates.
Primary Purpose
Ovarian Cancer, Cervical Cancer, Uterine Cancer
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Oral Ferrous Fumarate
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Ovarian Cancer focused on measuring Anemia, Ovarian cancer, Uterine cancer, Cervical cancer, Oral iron
Eligibility 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.
Sites / Locations
- Odette Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ferrous Fumarate 300 mg + Vitamin C
Placebo + Vitamin C
Arm Description
300 mg once a day of Oral Ferrous Fumarate
300 mg of Placebo
Outcomes
Primary Outcome Measures
Mean Difference in Hemoglobin
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 Outcome Measures
Quality of life
The difference in quality of life (FACT-An) between patients treated with ferrous fumarate 300 mg. daily to placebo.
Full Information
NCT ID
NCT01953107
First Posted
August 26, 2013
Last Updated
May 11, 2021
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01953107
Brief Title
Oral Iron vs. Placebo in Newly Diagnosed Gynecologic Oncology Patients Who Are Surgical Candidates.
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 Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Cervical Cancer, Uterine Cancer, Anemia
Keywords
Anemia, Ovarian cancer, Uterine cancer, Cervical cancer, Oral iron
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ferrous Fumarate 300 mg + Vitamin C
Arm Type
Experimental
Arm Description
300 mg once a day of Oral Ferrous Fumarate
Arm Title
Placebo + Vitamin C
Arm Type
Placebo Comparator
Arm Description
300 mg of Placebo
Intervention Type
Other
Intervention Name(s)
Oral Ferrous Fumarate
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean Difference in Hemoglobin
Description
The mean difference in the change of hemoglobin levels from baseline to the day of surgery between participants treated with oral iron versus. placebo.
Time Frame
Pre-surgery (4-6 weeks)
Secondary Outcome Measure Information:
Title
Quality of life
Description
The difference in quality of life (FACT-An) between patients treated with ferrous fumarate 300 mg. daily to placebo.
Time Frame
Baseline to Pre-surgery (4-6 weeks)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Vicus, MD
Organizational Affiliation
Odette Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Oral Iron vs. Placebo in Newly Diagnosed Gynecologic Oncology Patients Who Are Surgical Candidates.
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