NCT01953107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4 ovarian-cancer

Timeline
Completed

Started Nov 2013

Longer than P75 for phase_4 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

3.2 years

First QC Date

August 26, 2013

Last Update Submit

May 11, 2021

Conditions

Ovarian CancerCervical CancerUterine CancerAnemia

Keywords

AnemiaOvarian cancerUterine cancerCervical cancerOral iron

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality of life

    Baseline to Pre-surgery (4-6 weeks)

Study Arms (2)

Ferrous Fumarate 300 mg + Vitamin C

EXPERIMENTAL

300 mg once a day of Oral Ferrous Fumarate

Other: Oral Ferrous Fumarate

Placebo + Vitamin C

PLACEBO COMPARATOR

300 mg of Placebo

Other: Placebo

Interventions

Oral Ferrous FumarateOTHER
Ferrous Fumarate 300 mg + Vitamin C
PlaceboOTHER
Placebo + Vitamin C

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Ovarian NeoplasmsUterine Cervical NeoplasmsUterine NeoplasmsAnemia

Interventions

ferrous fumarate

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine Cervical DiseasesUterine DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Danielle Vicus, MD

    Odette Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical Oncologist - Gynecologic Oncology

Study Record Dates

First Submitted

August 26, 2013

First Posted

September 30, 2013

Study Start

November 1, 2013

Primary Completion

January 1, 2017

Study Completion

December 1, 2020

Last Updated

May 12, 2021

Record last verified: 2021-05

Locations

CA(1)