Erythropoietin efficiency in thalassemia

Phase 3

• Conditions: Condition 1: breast cancer. Condition 2: colon cancer. Condition 3: Rectal cancer. Condition 4: Gastric cancer. Condition 5: Esophageal cancer. Condition 6: Head & Neck cancer. Condition 7: Thalassemia beta minor.; Malignant neoplasm of breast; Malignant neoplasm of colon; Malignant neoplasm of rectum; Malignant neoplasm of stomach; Malignant neoplasm of esophagus; Malignant neoplasm of other and ill-defined sites; Thalassemia minor; D56.3

• Registration Number: IRCT20211202053252N1
• Lead Sponsor: Babol University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Aged over 18 years old
Metastatic cancer patients on first-line chemotherapy plan
Patients with visceral(confirmed with CT scan or MRI) or/and bone(less than 5-confirmed with bone scintigraphy) metastases
Initial serum hemoglobin less than 13 g/d

Exclusion Criteria

Leukemia/Plasma cell dyscrasia
Less than 3 months life expectancy
Major and intermedia thalassemia based on hemoglobin electrophoresis
Patients at risk for vascular thromboembolism(e.g. history of venous thromboembolism or ischemic stroke, patients with metallic prostheses in heart or vessels(excluding coronary stents after one year of placement)
Taking drugs which effect on estrogen/progesterone receptor or any other drug that raises risk of thromboembolism during chemotherapy
Pregnancy
Uncontrolled high blood pressure(systolic BP over 160mmHg or diastolic BP over 95mmHg in three visits within a month despite treatment)
A history of taking therapeutic radiopharmaceuticals in past three months
A history of blood transfusion within three months before trial initiation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum hemoglobin level. Timepoint: Before study, with each chemotherapy session. Method of measurement: Electrical-Impedance Cell Counting.;Shortness of breath. Timepoint: Before study, with each chemotherapy session. Method of measurement: Subjective _ According to NYHA Classification of dyspnea.