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

This study is currently recruiting participants.
Verified April 2017 by Dr. Danielle Vicus, Sunnybrook Health Sciences Centre
Sponsor:
ClinicalTrials.gov Identifier:
NCT01953107
First Posted: September 30, 2013
Last Update Posted: April 25, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Danielle Vicus, Sunnybrook Health Sciences Centre
  Purpose

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 Intervention Phase
Ovarian Cancer Cervical Cancer Uterine Cancer Anemia Other: Oral Ferrous Fumarate Other: Placebo Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Dr. Danielle Vicus, Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 200
Study Start Date: November 2013
Estimated Study Completion Date: November 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01953107


Contacts
Contact: Amanda Fonseca, Clinical Research Associate 416-480-5000 ext 89828 amanda.fonseca@sunnybrook.ca

Locations
Canada, Ontario
Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Principal Investigator: Dr. Danielle Vicus, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Danielle Vicus, MD Odette Cancer Centre
  More Information

Responsible Party: Dr. Danielle Vicus, Surgical Oncologist - Gynecologic Oncology, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01953107     History of Changes
Other Study ID Numbers: GYNEOCC2
First Submitted: August 26, 2013
First Posted: September 30, 2013
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Dr. Danielle Vicus, Sunnybrook Health Sciences Centre:
Anemia
Ovarian cancer
Uterine cancer
Cervical cancer
Oral iron

Additional relevant MeSH terms:
Uterine Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Cervical Diseases
Uterine Diseases
Ferrous fumarate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs