NCT05910164

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Institut Rafael · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-09
• Primary completion: 2023-09-09
• Completion: 2024-10-09
• First posted: 2023-06-18
• Last updated: 2024-12-19

Locations

1 site across 1 country: France