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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05910164
Other study ID # IR-2022/0011
Secondary ID ID RCB: 2022-A01
Status Active, not recruiting
Phase
First received
Last updated
Start date June 9, 2023
Est. completion date October 9, 2024

Study information

Verified date July 2023
Source Institut Rafael
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Febrile neutropenia (NF) is a common serious complication of cancer chemotherapy. Outpatient management of chemotherapy treatments is made essential by the volume of patients treated, respect for their quality of life and the lack of hospitalization resources. The prevention of NF is well documented and its success depends on the risks of developing NF related to the type of chemotherapy protocol used and the profile of the patient and his disease. Pegfilgrastim (G-CSF, biosimilar medicine) injection has been shown to prevent (febrile) neutropenia. It is routinely prescribed on an outpatient basis for patients treated with chemotherapy (CT), several thousand times a year in our geographical area. In order to take into account patient preferences and help clinical decision-making, this study will be conducted on the basis of self-administered questionnaires. The aim of the research is to assess patient preference for receiving administration of PELGRAZ (Accord Healthcare) using a prefilled syringe or a prefilled pen device. In a second step, this study will evaluate the learning of the patient and his autonomy during a pen self-injection guided by a nurse.


Description:

Febrile neutropenia (NF) is a common serious complication of cancer chemotherapy. Outpatient management of chemotherapy treatments is made essential by the volume of patients treated, respect for their quality of life and the lack of hospitalization resources. The prevention of NF is well documented and its success depends on the risks of developing NF related to the type of chemotherapy protocol used and the profile of the patient and his disease. Pegfilgrastim (G-CSF, biosimilar medicine) injection has been shown to prevent (febrile) neutropenia. It is routinely prescribed on an outpatient basis for patients treated with chemotherapy (CT), several thousand times a year in our geographical area. In order to take into account patient preferences and help clinical decision-making, this study will be conducted on the basis of self-administered questionnaires. This research involves the administration/use of a product (PELGRAZ, Accord Healthcare) within its intended purpose. PELGRAZ prefilled syringe or prefilled pen are available on the European Union market. The study will be carried out using a crossover design. Two modes of administration (syringe and pen) will be compared. Each subject will receive either the sequence syringe then pen, or pen then syringe. The trial will be conducted among 150 cancer patients for whom a chemotherapy followed by the administration of pegfilgrastim is indicated. The primary endpoint is a composite endpoint consisting of several parameters related to patient preference.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date October 9, 2024
Est. primary completion date September 9, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years old and older - Patients with solid tumors, Hodgkin's lymphoma, non-Hodgkin's lymphoma and receiving myelosuppressive chemotherapy with a risk of NF of 10-20% (individual risk factors), or = 20% (primary prevention of neutropenia) and receiving PELGRAZ ® in accordance with CPR - Prediction of the risk of NF without filgrastim or pegfilgrastim determined according to the recommendations of the EORTC - ECOG = 2 - Free and informed consent obtained - Patient affiliated to a social security system or beneficiary of such a scheme Exclusion Criteria: - Pregnancy - Breastfeeding - Patients receiving concurrent radiotherapy - Second cancer treated with chemotherapy - Participation in any other clinical trial within 30 days prior to recruitment - Concomitant myelosuppressive therapy, e.g. ex. immunosuppressive therapy - History of severe hypersensitivity reaction to drugs intended for use and/or drugs derived from E. coli

Study Design


Related Conditions & MeSH terms


Intervention

Device:
PELGRAZ prefilled syringe or PELGRAZ prefilled pen
PELGRAZ prefilled syringe or PELGRAZ prefilled pen https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz

Locations

Country Name City State
France Institut Rafael Levallois-Perret Ile-de-France

Sponsors (1)

Lead Sponsor Collaborator
Institut Rafael

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary questionnaire The primary endpoint is a composite endpoint consisting of several parameters related to patient preference 120 days
Secondary questionnaire, specific questions patient learning and empowerment during self-injection
pain evaluation
duration of treatment;
patient satisfaction;
overview of the health, physical and psychological conditions of the patient according to his own perception;
120 days
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