Patient Preference for Pegfilgrastim (Neulasta®) Application Forms

Study Overview
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Brief Summary
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The study aims to compare two application forms (pre-filled syringe and On-body injector) of the same active drug (pegfilgrastim) in adult patients under chemotherapy regarding patient preference and health economics. Chemotherapy will be supported with pegfilgrastim for four subsequent chemotherapy cycles using alternating application forms.

Detailed Description
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Neutropenia is one of the most common side effects of myelosuppressive chemotherapy. Febrile neutropenia and infectious complications are associated with chemotherapy dose delays and reductions and an increased risk of hospitalization. Prophylaxis with recombinant G-CSFs reduces the incidence, severity and duration of CIN and the risk of developing FN. Pegfilgrastim is available for over 10 years and is specified in the SmPC to be applied at least 24 hours after cytotoxic chemotherapy. For this application patients often have to return to their physician one day after chemotherapy treatment for the sole purpose of receiving pegfilgrastim subcutaneous (s.c.) injection. For different reasons, some of the patients requiring pegfilgrastim may not be able to return at this day and thus may not receive pegfilgrastim in accordance with the SmPC. The On-body injector for pegfilgrastim provides an option for patients not to return to the clinic/medical office the day after chemotherapy for their pegfilgrastim injection. The kit includes a single-use prefilled syringe co-packed with the On-body injector for pegfilgrastim. The On-body injector is applied to the patient's skin at the day of chemotherapy treatment and it automatically delivers pegfilgrastim approximately 27 h after the On-body injector was applied to the patient's skin. Patient-reported outcomes on preference for either application form can help to guide physicians' treatment choice, particularly in terms of application of the same active substance, in this study pegfilgrastim. This study aims to compare the two application forms of pegfilgrastim (pegfilgrastim pre-filled syringe vs. On-body injector for pegfilgrastim) with regard to patient preference and health economy. A trial design with randomization of patients to receive the two application forms of pegfilgrastim in an alternating sequence for 4 cycles starting with either On-body injector for pegfilgrastim (Arm A) or pegfilgrastim pre-filled syringe (Arm B) was chosen. In this way, all patients will receive both application forms in order to be able to decide for their individual preference. Four cycles (that means each patient will receive each application form of pegfilgrastim twice) should be a sufficient number for the patient to make a decision. This design with two treatment arms serves to exclude a systematic bias that might be generated when starting with the same application form for all patients.

Official Title
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A Comparison of Pegfilgrastim (Neulasta®) Application Via Manual Injection Versus Injection Via an On-body Injector Regarding Patient Preference and Health Economics

Conditions
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Non Hodgkin Lymphoma, Breast Cancer

Intervention / Treatment
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* Device: On-body injector
* Device: Pre-filled syringe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with early breast cancer planned to receive 3 weekly or dose-dense anthracycline/cyclophosphamide combination or 3 weekly taxane containing chemotherapy regimen or patients with NHL planned to receive R-CHOP-14 or R-CHOP-21 immunochemotherapy as 1st-line treatment with the indication for G-CSF prophylaxis with pegfilgrastim for the prevention of FN and reduction in CIN duration. Patients have to be included before start of their (immuno-) chemotherapy. ECOG (Eastern Cooperative Oncology Group) performance status 0, 1 or 2 Life expectancy > 3 months Absolute neutrophil count ≥ 1.5 x 109/L Ability to read and understand German Signed informed consent Exclusion Criteria: Hypersensitivity to the active substance or to any of the excipients Subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving investigational agent(s) Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment Prior bone marrow or stem cell transplantion Subject of child-bearing potential is evidently pregnant (e.g. positive HCG (Human Chorionic Gonadotropin) test) or is breast feeding Subject is not using adequate contraceptive precautions. Other conditions which, in the opinion of the investigator, make participation in an investigational trial of this nature a poor risk Concerns for subject's compliance with the protocol procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Start with On-body injector<br>4 consecutive cycles of treatment in total, with 2 cycles of treatment with pegfilgrastim pre-filled syringe (PS) and 2 cycles of treatment with On-body injector (OBI) for pegfilgrastim in an alternating sequence (OBI-PS-OBI-PS) | Device: On-body injector<br>* Medical device for subcutaneous injection of a supportive medicine (Pegfilgrastim) automatically after 27 hours after application of device.<br>Device: Pre-filled syringe<br>* For subcutaneous injection of a supportive medicine (Pegfilgrastim).<br>|
| Experimental: Arm B: Start with pre-filled syringe<br>4 consecutive cycles of treatment in total, with 2 cycles of treatment with pegfilgrastim pre-filled syringe (PS) and 2 cycles of treatment with On-body injector (OBI) for pegfilgrastim in an alternating sequence (PS-OBI-PS-OBI) | Device: On-body injector<br>* Medical device for subcutaneous injection of a supportive medicine (Pegfilgrastim) automatically after 27 hours after application of device.<br>Device: Pre-filled syringe<br>* For subcutaneous injection of a supportive medicine (Pegfilgrastim).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference for type of pegfilgrastim application assessed via project specific survey answered after 4 applications. | Percentage of patients favoring pegfilgrastim application via On-body injector. Patients are answering the questionnaire after 4 applications of pegfilgrastim in total, with On-body injector and pre-filled syringes used in alternating sequence (each type of application administered two times in total). | 4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time point of pegfilgrastim application within a chemotherapy cycle | The number of hours between chemotherapy application and pegfilgrastim application in each of the 4 observed chemotherapy cycles. | 4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen) | 
| Patient preference for pegfilgrastim application assessed via project specific survey answered at time of enrollment | Percentage of patients favoring pegfilgrastim application via On-body injector. Patients are answering the questionnaire before initial application. | at enrollment | 
| Impact of type of pegfilgrastim application on daily life of the patient assessed by direct questioning using project specific patient survey. | Percentage of patients reporting a certain impact level with respect to the type of pegfilgrastim application. Patient questionnaires will be answered after pegfilgrastim application in each of the 4 observed chemotherapy cycles. | 4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen) | 
| Percentage of nurses favoring pegfilgrastim application via On-body injector at study start and at end of study as stated via a project specific nurse survey | Percentage of nurses favoring pegfilgrastim application via On-body injector. Nurses are answering the questionnaire at study start and at the end of the study. | from first enrollment to end of study of last patient at a site (= end of cycle 4 of last patient, expected to be latest 2.5 years after study start) | 
| Preference of investigators for either type of pegfilgrastim application at study start und at end of study assessed via project specific investigator survey | Percentage of investigators favoring pegfilgrastim application via On-body injector. Investigators are answering the questionnaire at study start and at the end of the study. | from first enrollment to end of study of last patient at a site (= end of cycle 4 of last patient, expected to be latest 2.5 years after study start) | 
| Cost factors for the health care system for both types of application of pegfilgrastim | Cost factors are assessed via project specific patient survey addressing time, travel expenses and support needed to receive pegfilgrastim application. | 4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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R-CHOP, G-CSF, Early breast cancer, Anthracycline/cyclophosphamide, 1st line, immunochemotherapy, taxane