Ovarian CancerPhase 4NCT01953107
Oral Iron vs. Placebo in Newly Diagnosed Gynecologic Oncology Patients Who Are Surgical Candidates.
A Phase 4 study testing Oral Ferrous Fumarate in people with Ovarian Cancer and Cervical Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Ovarian Cancer, Cervical Cancer, Uterine Cancer
- What is being tested?
- Oral Ferrous Fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Ovarian Cancer, Cervical Cancer, Uterine Cancer, Anemia
- Being tested
- Oral Ferrous Fumarate, Placebo
- Keywords
- Anemia, Ovarian cancer, Uterine cancer, Cervical cancer, Oral iron
- Medical subject headings
- Ovarian Neoplasms, Uterine Cervical Neoplasms, Uterine Neoplasms, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Ferrous FumarateOther
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Ferrous Fumarate 300 mg + Vitamin C | Experimental | 300 mg once a day of Oral Ferrous Fumarate Receives: Other: Oral Ferrous Fumarate |
| Placebo + Vitamin C | Placebo comparator | 300 mg of Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-surgery (4-6 weeks)
Secondary outcomes (1)
Quality of life
The difference in quality of life (FACT-An) between patients treated with ferrous fumarate 300 mg. daily to placebo.
Measured: Baseline to Pre-surgery (4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2017
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Danielle Vicus, Sunnybrook Health Sciences Centre
- Investigators
- Danielle Vicus, MD, Principal investigator, Odette Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953107
- Sponsor's protocol ID
- GYNEOCC2
- Status last verified
- May 2021
- First submitted
- 26 Aug 2013
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01953107
- Acronym / sponsor ID
- GYNEOCC2
- Conditions
- Ovarian Cancer, Cervical Cancer, Uterine Cancer, Anemia
- Keywords
- Anemia, Ovarian cancer, Uterine cancer, Cervical cancer, Oral iron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous Fumarate 300 mg + Vitamin C | Experimental | Other: Oral Ferrous Fumarate300 mg once a day of Oral Ferrous Fumarate |
| Placebo + Vitamin C | Placebo comparator | Other: Placebo300 mg of Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Ferrous Fumarate | Other | Ferrous Fumarate 300 mg + Vitamin C |
| Placebo | Other | Placebo + Vitamin C |
Primary outcome
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.
1 secondary outcome
Quality of life
Time frame: Baseline to Pre-surgery (4-6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Vicus, MD principal investigator
Odette Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Ferrous Fumarate in people with Ovarian Cancer and Cervical Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference in Hemoglobin (time frame: Pre-surgery (4-6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.