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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Sunnybrook Health Sciences Centre
Sponsor:
Information provided by (Responsible Party):
Dr. Danielle Vicus, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01953107
First received: August 26, 2013
Last updated: January 27, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Mean Difference in Hemoglobin [ Time Frame: Pre-surgery (4-6 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 2016
Estimated Primary Completion Date: November 2015 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953107

Contacts
Contact: Jessica Marer, Clinical Research Associate 416-480-5000 ext 7387 jessica.marer@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

No publications provided

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
Study First Received: August 26, 2013
Last Updated: January 27, 2014
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Anemia
Ovarian cancer
Uterine cancer
Cervical cancer
Oral iron

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

ClinicalTrials.gov processed this record on August 01, 2014