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

Institut Rafael

Status: Completed

Conditions: Patient Preference; Patient Satisfaction; Febrile Neutropenia, Drug-Induced

Treatments: Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen

Study type: Observational

Funder types: Other

Identifiers

NCT05910164

IR-2022/0011

ID RCB: 2022-A01465-38 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

A) administration starting with prefilled syringe

Description:

- Group A = Phase 1 then phases 2, 3, 4 The study protocol consists of 4 different stages * Phase 1: injection by pre-filled syringe by a state-certified nurse (IDE) * Phase 2: pen injection guided (thanks to the detailed information) by the IDE * Phase 3: injection by pen in autonomy supervised by the IDE (can only interfere in case of non-compliance with the injection protocol) = Learning phase * Phase 4: injection by pen in complete autonomy, patient alone

Treatment:

Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen

B) administration starting with prefilled pen

Description:

- Group B = Phase 2, 3, 4 then phase 1 The study protocol consists of 4 different stages * Phase 1: injection by pre-filled syringe by a state-certified nurse (IDE) * Phase 2: pen injection guided (thanks to the detailed information) by the IDE * Phase 3: injection by pen in autonomy supervised by the IDE (can only interfere in case of non-compliance with the injection protocol) = Learning phase * Phase 4: injection by pen in complete autonomy, patient alone

Treatment:

Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen