Erythropoietin and Iron Supplementation for Patients With Chemotherapy-induced Anaemia

• Status: Unknown status
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai East Hospital
• Treatments: Dextrans; Epoetin Alfa; Iron; Iron-Dextran Complex

Criteria

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.