None listed
Conditions
Brief summary
The study aims to compare prophylactic versus hemoglobin-based erythropoietin administration in patients receiving cytotoxic chemotherapy for early or advanced cancer. Eligible patients are randomized in two groups: Patients in Group A (experimental arm) receive prophylactic ESA (epoetin A, 10.000IU x 3 times weekly, subcutaneous infusion) with iron supplementation (Resoferon 10mg daily per os or Legofer 10mg, taken in 2 drinking ampoules) with a target hemoglobin level of 14 mg/dl. If hemoglobin levels exceed this threshold, ESA administration is discontinued and is resumed when hemoglobin levels fell under 12 mg/dl. In group B, patients receive only iron supplementation (Resoferon 10mg daily per os or Legofer 10mg, taken in 2 drinking ampoules) and ESA administration is initiated if hemoglobin levels fall below 11 mg/dl and are continued with a target of 13 mg/dl, at which point ESA support is discontinued, only to be resumed if hemoglobin levels fall again below 11 mg/dl. In both groups ESA administration is to be continued for four weeks after cessation of chemotherapy. The primary end-point of the study is safety, with emphasis on a composite outcome of thrombosis-related adverse events, while secondary endpoints include progression-free survival and overall survival.
Interventions
Prophylactic use of Erythropoietin-A, (epoetin-A 10.000IU x 3 times weekly, subcutaneous infusion) with iron supplementation (Resoferon 10mg daily orally or Legofer 10mg, taken daily in 2 drinking ampoules, participant preference). The administration begins at chemotherapy initiation and continues until the value of Hb is >=14 gr/dl . The administration of Erythropoietin begins again when the value of Hb is <=12 gr/dl. The dose remains the same.
The administration of Erythropoietin ends 4 wee
Prophylactic use of Erythropoietin-A, (epoetin-A 10.000IU x 3 times weekly, subcutaneous infusion) with iron supplementation (Resoferon 10mg daily orally or Legofer 10mg, taken daily in 2 drinking ampoules, participant preference). The administration begins at chemotherapy initiation and continues until the value of Hb is >=14 gr/dl . The administration of Erythropoietin begins again when the value of Hb is <=12 gr/dl. The dose remains the same. The administration of Erythropoietin ends 4 weeks after the last cycle of chemotherapy. Daily iron treatment continues thoughout the intervention period regardless of Hb levels.
Sponsors
Hellenic Cooperative Oncology Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Histologically confirmed cancer -Hemoglobin more or equal to 11-13gr/dl -Scheduled Treatment duration more than three months -Age more or equal to 18 years -Performance Status 0-2 (World Health Organisation) -Negative Pregnancy Test -Life Expectancy more or equal to 4 months -Sufficiency of vitamin B12 (>200 pg/ml) or folic acid (>2.5 ng/ml) -Sufficiency of iron (transferrin saturation >15%, ferritin >50 ng/ml) -Signed informed consent - Patients were to be scheduled to begin chemotherapy within 4 weeks after study enrolment
Exclusion criteria
-Anaemia (Hb< 11 mg/dl) due to cancer -Previous Erythropoietin Administration for any reason -Scheduled Treatment duration less than three months -Life Expectancy less than six months
Outcome results
None listed