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

Ovarian Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953107
• Other study ID #: GYNEOCC2
• Status: Completed
• Phase: Phase 4
• Start date: November 2013
• Est. completion date: December 2020

Study information

• Verified date: May 2021
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Cervical Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Uterine Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Other:
• Oral Ferrous Fumarate

• Placebo

Locations

Country	Name	City	State
Canada	Odette Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-surgery (4-6 weeks)
Secondary	Quality of life	The difference in quality of life (FACT-An) between patients treated with ferrous fumarate 300 mg. daily to placebo.	Baseline to Pre-surgery (4-6 weeks)