Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients receiving platinum based chemotherapy than oral iron?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection

NCT01043172

Cholangiocarcinoma

COMPLETED PHASE2

A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy

NCT01876693

Carcinoma, Squamous Cell of Head and Neck

TERMINATED NA

Retrospective Study of Brachytherapy

NCT05242861

Brachytherapy Uterine Cervical Neoplasms Uterine Neoplasms +4 more

RECRUITING

A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients

NCT00373620

Endometrial Cancer

UNKNOWN PHASE2

Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma

NCT02193594

Gastroesophageal Junction Adenocarcinoma

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Gynecologic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intravenous iron

Iron sucrose 200 mg intravenous infusion in 15 minutes

Group Type EXPERIMENTAL

Intravenous iron

Intervention Type DRUG

Intravenous iron 200 mg add in 0.9% Normal saline 100 ml infused within 15 minutes after every cycles of chemotherapy

Oral iron

Ferrous fumarate 200 mg oral three times a day

Group Type PLACEBO_COMPARATOR

Intravenous iron

Intervention Type DRUG

Intravenous iron 200 mg add in 0.9% Normal saline 100 ml infused within 15 minutes after every cycles of chemotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravenous iron

Intravenous iron 200 mg add in 0.9% Normal saline 100 ml infused within 15 minutes after every cycles of chemotherapy

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Venofer

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Iron hypersensitivity
* Underlying disease which has the risk of iron overload such as chronic kidney disease, major thalassemia
* Progressive disease
* Bone marrow metastasis

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No