Patient Preference Between a Prefilled Syringe or a Prefilled Pen Device for Administration of Pegfilgrastim
NCT ID: NCT05910164
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
150 participants
OBSERVATIONAL
2023-06-09
2024-10-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CROSSOVER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A) administration starting with prefilled syringe
\- 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
PELGRAZ prefilled syringe or PELGRAZ prefilled pen
PELGRAZ prefilled syringe or PELGRAZ prefilled pen https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz
B) administration starting with prefilled pen
\- 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
PELGRAZ prefilled syringe or PELGRAZ prefilled pen
PELGRAZ prefilled syringe or PELGRAZ prefilled pen https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PELGRAZ prefilled syringe or PELGRAZ prefilled pen
PELGRAZ prefilled syringe or PELGRAZ prefilled pen https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut Rafael
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alain TOLEDANO, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Rafael
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut Rafael
Levallois-Perret, Île-de-France Region, France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Scher N, Boudabous H, Partouche J, Rezaee-Vessal S, Ihout P, Rizzo C, Lamallem H, Bauduceau O, Darmon I, Bollet M, Draghi C, Toledano A. Enhancing patient-centered care: a randomized study on G-CSF administration preferences in chemotherapy-induced neutropenia. Support Care Cancer. 2024 Oct 22;32(11):743. doi: 10.1007/s00520-024-08929-x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ID RCB: 2022-A01465-38
Identifier Type: OTHER
Identifier Source: secondary_id
IR-2022/0011
Identifier Type: -
Identifier Source: org_study_id