Gynecologic CancerPhase 3NCT01435200
Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy
A Phase 3 study testing Intravenous iron in people with Gynecologic Cancer, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients receiving platinum based chemotherapy than oral iron? Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Intravenous iron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2011to Nov 2012
- Phase
- Phase 3
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-70 years
- Good performance status (Zubrod score < 2)
- No serious underlying disease
- Normal renal function test
- Normal liver function test
- Platinum based chemotherapy is the first line regimen
- No prior or receiving radiotherapy
Who cannot join
- Iron hypersensitivity
- Underlying disease which has the risk of iron overload such as chronic kidney disease, major thalassemia
- Progressive disease
- Bone marrow metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Blood Transfusion With Intravenous Iron in Gynecologic Cancer Patients Receiving Platinum Based Chemotherapy
Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients receiving platinum based chemotherapy than oral iron?
Read the detailed description
Anemia is a common condition during chemotherapy administration. Treatment options usually include oral iron supplementation and blood transfusion. However, oral iron has gastrointestinal side effects, which affects patient compliance, and only a small amount of oral iron can be absorbed from the gastrointestinal tract. Intravenous iron may overcome a block of iron absorption and iron recycling induced by hepcidin. Therefore, it may increase hemoglobin level and reduced blood transfusion in cancer patients receiving chemotherapy.
- Conditions
- Gynecologic Cancer
- Being tested
- Intravenous iron
- Keywords
- Intravenous iron, gynecologic cancer blood transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ironDrug
Also called Venofer
Intravenous iron 200 mg add in 0.9% Normal saline 100 ml infused within 15 minutes after every cycles of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intravenous iron | Experimental | Iron sucrose 200 mg intravenous infusion in 15 minutes Receives: Drug: Intravenous iron |
| Oral iron | Placebo comparator | Ferrous fumarate 200 mg oral three times a day Receives: Drug: Intravenous iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell (RBC) transfusion rate
The requirement of red blood cell transfusion before administration of chemotherapy will be evaluated for 6 cycles of chemotherapy.
Measured: 6 months
Secondary outcomes (2)
total number of red blood transfusion units and number of cycles requiring blood transfusion
Measured: 6 months
Number of participants with adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarinee Manchana, Chulalongkorn University
- Investigators
- Tarinee Manchana, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435200
- Sponsor's protocol ID
- IV iron 2
- Status last verified
- Jan 2017
- First submitted
- 14 Sep 2011
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Athibovonsuk P, Manchana T, Sirisabya N. Prevention of blood transfusion with intravenous iron in gynecologic cancer patients receiving platinum-based chemotherapy. Gynecol Oncol. 2013 Dec;131(3):679-82. doi: 10.1016/j.ygyno.2013.09.028. Epub 2013 Oct 5.
PubMed 24099839
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Blood Transfusion With Intravenous Iron in Gynecologic Cancer Patients Receiving Platinum Based Chemotherapy
- ClinicalTrials.gov ID
- NCT01435200
- Acronym / sponsor ID
- IV iron 2
- Conditions
- Gynecologic Cancer
- Keywords
- Intravenous iron, gynecologic cancer blood transfusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Sep 2011 (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.
Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients receiving platinum based chemotherapy than oral iron?
Detailed description
Anemia is a common condition during chemotherapy administration. Treatment options usually include oral iron supplementation and blood transfusion. However, oral iron has gastrointestinal side effects, which affects patient compliance, and only a small amount of oral iron can be absorbed from the gastrointestinal tract. Intravenous iron may overcome a block of iron absorption and iron recycling induced by hepcidin. Therefore, it may increase hemoglobin level and reduced blood transfusion in cancer patients receiving chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous iron | Experimental | Drug: Intravenous ironIron sucrose 200 mg intravenous infusion in 15 minutes |
| Oral iron | Placebo comparator | Drug: Intravenous ironFerrous fumarate 200 mg oral three times a day |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 20-70 years
- Good performance status (Zubrod score < 2)
- No serious underlying disease
- Normal renal function test
- Normal liver function test
Key exclusion criteria (4 listed)
- Iron hypersensitivity
- Underlying disease which has the risk of iron overload such as chronic kidney disease, major thalassemia
- Progressive disease
- Bone marrow metastasis
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 |
|---|---|---|
| Intravenous ironAlso: VenoferIntravenous iron 200 mg add in 0.9% Normal saline 100 ml infused within 15 minutes after every cycles of chemotherapy | Drug | Intravenous iron, Oral iron |
Primary outcome
Red blood cell (RBC) transfusion rate
Time frame: 6 months
The requirement of red blood cell transfusion before administration of chemotherapy will be evaluated for 6 cycles of chemotherapy.
2 secondary outcomes
total number of red blood transfusion units and number of cycles requiring blood transfusion
Time frame: 6 months
Number of participants with adverse events
Time frame: 6 months
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 1 Feb 2017.
- Derived from this study: PubMed 24099839Athibovonsuk P, Manchana T, Sirisabya N. Prevention of blood transfusion with intravenous iron in gynecologic cancer patients receiving platinum-based chemotherapy. Gynecol Oncol. 2013 Dec;131(3):679-82. doi: 10.1016/j.ygyno.2013.09.028. Epub 2013 Oct 5.
- Individual participant dataSharing planned: No
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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.
Tarinee Manchana, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous iron in people with Gynecologic Cancer, run by Chulalongkorn University at 1 site in Thailand.
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 7 inclusion and 4 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 1 Feb 2017. 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 Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Red blood cell (RBC) transfusion rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01435200, which also lists 1 linked publication.
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 1 Feb 2017.