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

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Completed

CT.gov ID

NCT01953107

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer Cervical Cancer Uterine Cancer Anemia	Other: Oral Ferrous Fumarate Other: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

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 :

Nov 1, 2013

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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	Other: Placebo

Arm

Intervention/Treatment

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

Other: Placebo

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.