Patient Preference Between a Prefilled Syringe or a Prefilled Pen Device for Administration of Pegfilgrastim

Patient Satisfaction Clinical Trial

— PELGRAZ  

Official title:

Single-center, Randomized, Crossover Clinical Study to Assess Patient Preference Between the Use of a Prefilled Syringe or a Prefilled Pen Device for Pegfilgrastim Administration (PELGRAZ) as Primary Prophylaxis of Chemotherapy-related Neutropenia

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
• 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
• 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

Related Conditions & MeSH terms

• Chemotherapy-Induced Febrile Neutropenia
• Febrile Neutropenia
• Febrile Neutropenia, Drug-Induced
• Neutropenia
• Patient Preference
• Patient Satisfaction

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