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Erythropoietin and Iron Supplementation for Patients With Chemotherapy-induced Anaemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02731378
Recruitment Status : Unknown
Verified October 2016 by Chen Lin, Shanghai East Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 7, 2016
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Chen Lin, Shanghai East Hospital

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

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Anaemia Drug: Erythropoietins (EPO) Drug: Aggressive iron dextran supplementation Drug: Sustained iron dextran supplementation Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 603 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination With Intravenous Iron Supplementation or Doubling Erythropoietin Dose for Patients With Chemotherapy-induced Anaemia Inadequately Responsive to Initial Erythropoietin Treatment Alone
Study Start Date : December 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: 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
Drug: Erythropoietins (EPO)
A routine dose 10,000 IU of EPO, three times weekly by subcutaneous injections.

Drug: Sustained iron dextran supplementation
Iron dextran 200 mg, Q3W, through 90 minutes of IV infusion and a maximum of 5 doses

Experimental: 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
Drug: Erythropoietins (EPO)
A routine dose 10,000 IU of EPO, three times weekly by subcutaneous injections.

Drug: Aggressive iron dextran supplementation
Iron dextran 100 mg, BIW, through 90 minutes of IV infusion, for the first consecutive 5 weeks

Active Comparator: Double EPO
Group 3, the control group, doubling the EPO dose without preplanned iron supplementation
Drug: Erythropoietins (EPO)
Doubling EPO dosage to 20,000 IU, three times weekly by subcutaneous injections with a maximum of 5 doses




Primary Outcome Measures :
  1. Hb response rate [ Time Frame: up to week 15 ]
    A CIA patient would be defined as an Hb responder to study treatment if either Hb concentration of this patient is at least 12 g/dL or there is an increase in Hb levels of more than 2-g/dL compared to baseline level without blood transfusions initiated in the previous 28 days.


Secondary Outcome Measures :
  1. Proportions of patients requiring therapeutic blood transfusions [ Time Frame: Within 15 weeks ]
  2. Time-to-progression (TTP) [ Time Frame: Baseline, week 15, and then once per 3 months in the first year and once per 6 months thereafter up to 2 years ]
  3. Volume of transfused blood [ Time Frame: Within 15 weeks ]

Other Outcome Measures:
  1. Adverse events (AEs) [ Time Frame: Through study completion, up to 2 years ]
  2. Quality of life - Linear Analogue Self-Assessment test [ Time Frame: Baseline and week 3, 6, 9, 12 and 15 ]
  3. Quality of life - Functional Assessment of Cancer Therapy-Anaemia test [ Time Frame: Baseline and week 3, 6, 9, 12 and 15 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731378


Contacts
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Contact: Lin Chen, Master 8621-38804518 ext 17216 896571345@qq.com
Contact: Yong Gao, PhD 8621-38804518 ext 17216 drgaoyong@163.com

Locations
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China, Shanghai
Shanghai East Hospital Home Branch
Shanghai, Shanghai, China
Contact: Hong Jiang    021-38804518-17216    jianghong2046@126.com   
Shanghai East Hospital South Branch
Shanghai, Shanghai, China
Contact: Yong Gao, PhD    021-38804518    drgaoyong@163.com   
Shanghai First People's Hospital
Shanghai, Shanghai, China
Contact: Qi Li    021-63240090    yoursgaowei@163.com   
Shanghai Sixth People's Hospital Lingang Branch
Shanghai, Shanghai, China
Contact: Daliu Min    021-64369181    dan16065@163.com   
The First Affiliated Hospital, The Second Military Medical University
Shanghai, Shanghai, China
Contact: Chuangang Fu    021-31166666    fugang416@126.com   
China, Zhejiang
Shanghai East Hospital Jian Branch
Jian, Zhejiang, China
Contact: Ying Zhou    0796-8311066    yjm_st@163.com   
Sponsors and Collaborators
Shanghai East Hospital
Investigators
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Principal Investigator: Yong Gao, PhD Shanghai East Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chen Lin, Dr., Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT02731378    
Other Study ID Numbers: 2016003
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Chen Lin, Shanghai East Hospital:
erythropoietin
iron supplementation
inadequately responsive
chemotherapy-induced anaemia
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Iron
Dextrans
Epoetin Alfa
Iron-Dextran Complex
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Anticoagulants
Plasma Substitutes
Blood Substitutes