Oral Iron vs. Placebo in Newly Diagnosed Gynecologic Oncology Patients Who Are Surgical Candidates.

Phase 4

Completed

• Conditions: Ovarian Cancer; Anemia; Uterine Cancer; Cervical Cancer
• Interventions: Other: Placebo; Other: Oral Ferrous Fumarate

• Registration Number: NCT01953107
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-09-25
• Study First Posted: 2013-09-30
• Study Start: 2013-11
• Primary Completion: 2017-01
• Study Completion: 2020-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Vitamin C	Placebo	300 mg of Placebo
Ferrous Fumarate 300 mg + Vitamin C	Oral Ferrous Fumarate	300 mg once a day of Oral Ferrous Fumarate

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada