Erythropoietin and Iron Supplementation for Patients With Chemotherapy-induced Anaemia

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

603 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-11-30

Brief Summary

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A multicentre, randomized, open-label, parallel-group, active controlled non-inferiority study

Detailed Description

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Chemotherapy-induced anaemia (CIA) is a significant health problem for patients with cancer undergoing chemotherapy, causing fatigue and reducing quality of life (QoL). Up to 75% of cancer patients undergoing chemotherapy and/or radiotherapy reportedly experience mild-to-moderate anaemia (defined by a haemoglobin level of 9 to 11 g/dL). In clinical trials, erythropoietins (EPOs) have been shown to increase haemoglobin levels and improve anaemia and QoL in cancer patients. However, recent meta-analyses have highlighted possible safety issues regarding EPO exposure. Preclinical studies have pointed towards the role of EPO in augmenting tumorigenesis, metastasis, risk of thrombosis, and drug resistance in certain tumor types (e.g., breast cancer), as it can activate important antiapoptotic pathways targeted by current antineoplastic therapies, thus counteracting their effects. Current guidelines in western countries and China recommend restricted usage of EPOs and reduction / prevention of blood transfusions in the treatment of cancer-induced anaemia.

However, the inadequate response to erythropoietic therapy has not been well-characterized through rigorous studies and hence remains poorly handled in routine clinical practice. A major cause for not responding to EPO treatment is likely functional iron deficiency (FID), which is defined as a failure to provide iron to the erythroblasts despite sufficient iron stores. Patients with FID require supplementation of usable iron to optimize response to erythropoietic therapy, which might not be accomplished with oral iron. In a recent prospective, open-label trial, patients receiving epoetin alfa for CIA who were treated with IV iron dextran had a significantly greater Hb response compared with those receiving oral iron. Meanwhile, in patients with CIA and no iron deficiency, IV iron supplementation significantly reduced treatment failures to darbepoetin without additional toxicity. However, whether that IV iron supplementation increases the risk of disease progression, incidence of thrombosis and heart failure as well as iron overload, is under careful investigation. Though the association between IV iron and serious AEs and mortality remains unclear, Zitt et al. found that the use of IV iron was associated with a 22% reduction in mortality. Therefore, investigators designed this multicentre, randomized trial to investigate EPOs in combination with IV iron with regard to an increase of Hb levels in patients who have inadequate responses to initial treatment with routine doses of EPOs.

Conditions

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Chemotherapy-induced Anaemia

Keywords

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erythropoietin iron supplementation inadequately responsive chemotherapy-induced anaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EPO plus sustained iron dextran

Group 1, EPO treatment at the original dose plus IV iron dextran 200 mg every three weeks (Q3W) for 15 weeks

Group Type EXPERIMENTAL

Erythropoietins (EPO)

Intervention Type DRUG

A routine dose 10,000 IU of EPO, three times weekly by subcutaneous injections.

Sustained iron dextran supplementation

Intervention Type DRUG

Iron dextran 200 mg, Q3W, through 90 minutes of IV infusion and a maximum of 5 doses

EPO plus aggressive iron dextran

Group 2, EPO treatment at the original dose plus IV iron dextran 100 mg, twice a week (BIW) for five weeks

Group Type EXPERIMENTAL

Erythropoietins (EPO)

Intervention Type DRUG

A routine dose 10,000 IU of EPO, three times weekly by subcutaneous injections.

Aggressive iron dextran supplementation

Intervention Type DRUG

Iron dextran 100 mg, BIW, through 90 minutes of IV infusion, for the first consecutive 5 weeks

Double EPO

Group 3, the control group, doubling the EPO dose without preplanned iron supplementation

Group Type ACTIVE_COMPARATOR

Erythropoietins (EPO)

Intervention Type DRUG

Doubling EPO dosage to 20,000 IU, three times weekly by subcutaneous injections with a maximum of 5 doses

Interventions

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Erythropoietins (EPO)

A routine dose 10,000 IU of EPO, three times weekly by subcutaneous injections.

Intervention Type DRUG

Aggressive iron dextran supplementation

Iron dextran 100 mg, BIW, through 90 minutes of IV infusion, for the first consecutive 5 weeks

Intervention Type DRUG

Erythropoietins (EPO)

Doubling EPO dosage to 20,000 IU, three times weekly by subcutaneous injections with a maximum of 5 doses

Intervention Type DRUG

Sustained iron dextran supplementation

Iron dextran 200 mg, Q3W, through 90 minutes of IV infusion and a maximum of 5 doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years or older;
* Had histologically, cytologically or clinically diagnosed malignant tumour and measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1;
* Undergoing adjuvant or palliative chemotherapy with an expected survival of at least 3 months;
* Inadequately responsive or unresponsive to routine dosages of EPO treatment. Inadequate responders or nonresponders are defined as those CIA patients with an increase of Hb \< 1g/dL after 4 weeks of treatment with 10, 000 IU of EPO, three times weekly by subcutaneous injection).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2;
* Are compliant and can understand the research and sign an informed consent form.

Exclusion Criteria

* History of thromboembolism in the previous twelve months;
* Family history of hemochromatosis;
* Anaemia diagnosed with myelodysplastic syndrome or hematologic diseases such as Mediterranean anaemia;
* Received EPO treatment in the prior three months;
* Received erythrocyte suspension transfusion in the prior two weeks;
* Women who are pregnant or lactating;
* Have a history of hypertension or mental illness.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Chen Lin

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong Gao, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital

Locations

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