Clinical trial NCT05910164: Patient Preference Between a Prefilled Syringe or a Prefilled Pen Device for Administration of Pegfilgrastim
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Preference
Febrile Neutropenia, Drug-Induced
Patient Satisfaction
Keywords: patient preference
pegfilgrastim
chemotherapy prophylaxis
febrile neutropenia
survey
questionnaires
Lead sponsor: Institut Rafael
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 150 patients for whom a chemotherapy treatment followed by PELGRAZ administration is indicated

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: questionnaire
timeFrame: 120 days
Secondary outcomes:
measure: questionnaire, specific questions
timeFrame: 120 days
Other outcomes:
Locations:
city: Levallois-Perret
country: France
facility: Institut Rafael
state: Ile-de-France
Study officials:
affiliation: Institut Rafael
name: Alain TOLEDANO, MD
role: PRINCIPAL_INVESTIGATOR
References: