Patient PreferencePELGRAZNCT05910164
Patient Preference Between a Prefilled Syringe or a Prefilled Pen Device for Administration of Pegfilgrastim
An observational study of Patient Preference and Febrile Neutropenia, Drug-Induced, run by Institut Rafael at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Preference, Febrile Neutropenia, Drug-Induced, Patient Satisfaction
- What is being tested?
- PELGRAZ prefilled syringe or PELGRAZ prefilled pen
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2023to 9 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 150 patients for whom a chemotherapy treatment followed by PELGRAZ administration is indicated
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- PELGRAZ prefilled syringe or PELGRAZ prefilled pen
- Keywords
- patient preference, pegfilgrastim, chemotherapy prophylaxis, febrile neutropenia, survey, questionnaires
- Medical subject headings
- Patient Preference, Chemotherapy-Induced Febrile Neutropenia, Patient Satisfaction, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PELGRAZ prefilled syringe or PELGRAZ prefilled penDevice
PELGRAZ prefilled syringe or PELGRAZ prefilled pen https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen | |
| 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 Receives: Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire
The primary endpoint is a composite endpoint consisting of several parameters related to patient preference
Measured: 120 days
Secondary outcomes (1)
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;
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start9 Jun 2023
- Primary completion9 Sep 2023
- Study completion9 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient PreferenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Rafael
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain TOLEDANO, MD, Principal investigator, Institut Rafael
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910164
- Sponsor's protocol ID
- IR-2022/0011
- Other IDs
- ID RCB: 2022-A01465-38
- Acronym
- PELGRAZ
- Status last verified
- Sep 2024
- First submitted
- 9 Jun 2023
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39436413
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05910164
- Acronym / sponsor ID
- PELGRAZ / IR-2022/0011
- Keywords
- patient preference, pegfilgrastim, chemotherapy prophylaxis, febrile neutropenia, survey, questionnaires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institut RafaelUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 9 Sep 2023 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A) administration starting with prefilled syringe | – | Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen- 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 |
| B) administration starting with prefilled pen | – | Device: PELGRAZ prefilled syringe or PELGRAZ 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients for whom a chemotherapy treatment followed by PELGRAZ administration is indicated
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Pregnancy
- Breastfeeding
- Patients receiving concurrent radiotherapy
- Second cancer treated with chemotherapy
- Participation in any other clinical trial within 30 days prior to recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PELGRAZ prefilled syringe or PELGRAZ prefilled penPELGRAZ prefilled syringe or PELGRAZ prefilled pen https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz | Device | A) administration starting with prefilled syringe, B) administration starting with prefilled pen |
Primary outcome
questionnaire
Time frame: 120 days
The primary endpoint is a composite endpoint consisting of several parameters related to patient preference
1 secondary outcome
questionnaire, specific questions
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Derived from this study: PubMed 39436413Scher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain TOLEDANO, MD principal investigator
Institut Rafael
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Preference and Febrile Neutropenia, Drug-Induced, run by Institut Rafael at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaire (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05910164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.