Evaluation of the Correlation between fatigue and quality of life in patients with solid tumour, malignant lymphoma or multiple myeloma and treated with Binocrit® for a chemotherapy-induced anaemia (CIROCO)

Study identification

• EU PAS number:
  EUPAS11057
• Study ID:
  23646
• Official title and acronym:
  Evaluation of the Correlation between fatigue and quality of life in patients with solid tumour, malignant lymphoma or multiple myeloma and treated with Binocrit® for a chemotherapy-induced anaemia (CIROCO)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  CIROCO study is a national, multicenter, prospective, observational study. Anemia is a biological symptom frequently observed in cancer patients. While the latter maybe related to the cancer disease itself, it is most commonly the consequence of cancer-specific treatments, notably chemotherapy. ; Anemia is defined as a reduction in the total amount of circulating functional hemoglobin. ; Fatigue is the quality of life(QL)-impacting symptom which is the most commonly reported by patients with cancer undergoing chemotherapy, with an incidence of over 70 % of patients ; 1. Patients describe it as the symptom which most affects their daily life (67%), or even as their main problem (37%) ; 2.The EORTC QLQ C30 multicriteria scale 2 has been validated on over 10,000 patients and is widely used in clinical practice to evaluate the QL of cancer patients. The use of a single-criterion evaluation test such as the Fatigue Visual Analog Scale (VAS) which evaluates fatigue on a scale from 0 (no fatigue at all) to 10 (extreme fatigue), is considered, due to its simplicity, as the most appropriate way to self evaluate ; 3.Binocrit® (epoetin alfa), an erythropoeisis-stimulating agent, is administered to patients with chemotherapy-induced anaemia (CIA) with the aim of increasing their haemoglobin level, avoiding blood transfusions, and improving patient QL 4, notably by improving fatigue. The main objective of the study is to determine the correlation between fatigue, evaluated by VAS, and QL, using EORTC QLQ C30, perceived by patients with solid tumor, malignant lymphoma or multiple myeloma and treated with Binocrit® for a CIA. This study will also help to assess the perception that physicians have of their patients' fatigue. The patient's inclusion and follow-up in the study will occur as part of their usual care. No further tests are planned which could hinder the patients' usual treatment. All data collected will be anonymized.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Sandoz

Study timelines

Date when funding contract was signed

Planned: 02/03/2015

Actual: 02/03/2015

Study start date

Planned: 24/09/2015

Actual: 26/09/2015

Date of final study report

Planned: 31/08/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

SANDOZ

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable