Retrospective Study on the Incidence and Management of Anemia in Oncology (RESPIRE)

The incidence of anemia ranges from 20 to 75% depending on the type of cancer. It is often present at diagnosis and increases with specific treatments. It has an impact on overall survival and quality of life. Its origins are multiple (pure iron deficiency or functional, malnutrition, dyserythropoiesis, insufficiency renal, hemolysis, chemotherapy, radiotherapy, targeted therapies).

Transfusion is the most common treatment offered in the management of anemia. The incidence of anemia and its consequences are often underestimated during cancer management.

Recommendations were published in 2012. An inventory of the incidence of anemia before and after the publication of these recommendations are proposed in order to assess their impact on daily practice.

Study Overview

• Status: Completed
• Conditions: Cancer; Anemia
• Intervention / Treatment: Other: anemia assessment

• Study Type: Observational
• Enrollment (Actual): 349

Contacts and Locations

Study Locations

• France
  • Le Mans, France, 72000
    • Centre Jean Bernard - Clinique Victor Hugo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with cancer and justifying continuous hospitalization for more than one night regardless of pattern.

Patient informed and not having expressed opposition to the study.

Description

Inclusion Criteria:

• Age ≥ 18 years old,
• Follow-up for cancer justifying hospitalization,
• Presenting anemia defined by a hemoglobin level <11 g / dL,
• Patient not having objected to the collection of his data after oral and written information.

Exclusion Criteria:

• patients with a hemoglobin level ≥ 11 g / dL,
• adult patients under guardianship, curatorship or deprived of liberty,
• pregnancy or breast-feeding in progress at the time of hospitalization.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
period 2011	Other: anemia assessment; evaluation of anemia status
period 2018	Other: anemia assessment; evaluation of anemia status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of anemia	number of patient with anemia (<11.0 g/dL) upon admission to hospital on the number of patients hospitalized over the period	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of transfusion prescriptions	number of transfusions performed on the number of patients hospitalized over the period	2 years
Assessment of erythropoiesis stimulating agents (EPO) prescriptions	number of prescriptions for erythropoiesis stimulating agents (EPO)	2 years
Assessment of iron prescriptions	number of prescriptions of iron (oral and intravenous)	2 years
Time between last transfusion and date of death	Delay between the date of the last transfusion and the date of patient's death	2 years
overall survival	Delay between the enrollment date and the date of patient's death	2 years

Collaborators and Investigators

• Sponsor: Weprom
• Investigators: Principal Investigator: Katell LE DÛ, MD, Centre Jean Bernard/Clinique Victor Hugo - LE MANS

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: WP-2019-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No