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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01953107
Recruitment Status : Active, not recruiting
First Posted : September 30, 2013
Last Update Posted : April 23, 2018
Information provided by (Responsible Party):
Dr. Danielle Vicus, 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2013
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : December 2018

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

Primary Outcome Measures :
  1. Mean Difference in Hemoglobin [ Time Frame: 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 :
  1. Quality of life [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01953107

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Canada, Ontario
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Principal Investigator: Danielle Vicus, MD Odette Cancer Centre

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Responsible Party: Dr. Danielle Vicus, Surgical Oncologist - Gynecologic Oncology, Sunnybrook Health Sciences Centre Identifier: NCT01953107    
Other Study ID Numbers: GYNEOCC2
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Keywords provided by Dr. Danielle Vicus, Sunnybrook Health Sciences Centre:
Ovarian cancer
Uterine cancer
Cervical cancer
Oral iron
Additional relevant MeSH terms:
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Ovarian Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Uterine Cervical Diseases
Uterine Diseases
Ferrous fumarate
Growth Substances
Physiological Effects of Drugs
Trace Elements