To check if Inj Pegylated Erythropoietin, in low doses, reduces need of transfusion without causing much side effects and without disease effect on cancer outcome.

A single center Phase II randomized controlled trial to evaluate the safety and efficacy of low dose Pegylated Erythropoietin alpha in non-metastatic breast cancer patients with chemotherapy induced anemia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/035965

Enrollment

300

Registered

2021-08-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Pegylated Erythropoietin: Low dose Pegylated erythropoietin will be administered to non metastatic breast cancer patients on chemotherapy once in 2 weeks if hemoglobin drops below 10g/d

Eligibility

Inclusion criteria

Inclusion criteria: a) Age >18 years. b) Patients newly diagnosed with early breast cancer not on any chemotherapy or with 8 weeks or more of treatment remaining. c) Corrected underlying Iron or Vitamin B12 deficiency. d) Hemoglobin

Exclusion criteria

Exclusion criteria: a) Patients with history of DVT, PE or IHD history. b) Patients with performance status of ECOG 3 or more. c) Pregnant or breast-feeding women. d) Concomitant endocrine therapy. e) Uncontrolled hypertension.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of low dose erythropoietin (assessed by decrease in number of transfusion requirement) in patients undergoing chemotherapy for non-metastatic breast cancer with curative intent.Timepoint: At the end of chemotherapy I.e. 16 weeks	—

Secondary

Measure	Time frame
Assess impact on quality of lifeTimepoint: Pre and post chemotherapy;Evaluation of pCR rate at surgery (ypT0 ypN0, and ypT0/is)Timepoint: Post surgery;Impact on overall survival and progression free survival.Timepoint: long term follow up for 5 years;To assess the safety of low dose erythropoietin (which will be assessed by comparison of adverse events between groups).Timepoint: After completion of chemotherapy	—

Measure

Time frame

Assess impact on quality of lifeTimepoint: Pre and post chemotherapy;Evaluation of pCR rate at surgery (ypT0 ypN0, and ypT0/is)Timepoint: Post surgery;Impact on overall survival and progression free survival.Timepoint: long term follow up for 5 years;To assess the safety of low dose erythropoietin (which will be assessed by comparison of adverse events between groups).Timepoint: After completion of chemotherapy

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Countries

India

Contacts

Public ContactDr Ashish Singh

Christian Medical College Vellore

todrashish@gmail.com9445659460

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026