Clinical trial NCT03619993: Patient Preference for Pegfilgrastim (Neulasta®) Application Forms
Official title: A Comparison of Pegfilgrastim (Neulasta®) Application Via Manual Injection Versus Injection Via an On-body Injector Regarding Patient Preference and Health Economics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Hodgkin Lymphoma
Breast Cancer
Keywords: R-CHOP
G-CSF
Early breast cancer
Anthracycline/cyclophosphamide
1st line
immunochemotherapy
taxane
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2018-08-08
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient preference for type of pegfilgrastim application assessed via project specific survey answered after 4 applications.
timeFrame: 4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen)
Secondary outcomes:
measure: Time point of pegfilgrastim application within a chemotherapy cycle
timeFrame: 4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen)
measure: Patient preference for pegfilgrastim application assessed via project specific survey answered at time of enrollment
timeFrame: at enrollment
measure: Impact of type of pegfilgrastim application on daily life of the patient assessed by direct questioning using project specific patient survey.
timeFrame: 4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen)
measure: 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
timeFrame: 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)
measure: Preference of investigators for either type of pegfilgrastim application at study start und at end of study assessed via project specific investigator survey
timeFrame: 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)
measure: Cost factors for the health care system for both types of application of pegfilgrastim
timeFrame: 4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen)
Other outcomes:
measure: Resource utilization at site for either type of application assessed via project specific study nurse survey
timeFrame: at 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)
Locations:
city: Aschaffenburg
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Celle
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Flensburg
country: Germany
facility: Research Site
city: Frankfurt an der Oder
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Georgsmarienhütte
country: Germany
facility: Research Site
city: Goslar
country: Germany
facility: Research Site
city: Göttingen
country: Germany
facility: Research Site
city: Halberstadt
country: Germany
facility: Research Site
city: Halle (Saale)
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Herne
country: Germany
facility: Research Site
city: Hildburghausen
country: Germany
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Kaiserslautern
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Krefeld
country: Germany
facility: Research Site
city: Köthen
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Mayen
country: Germany
facility: Research Site
city: Moers
country: Germany
facility: Research Site
city: Mühlhausen
country: Germany
facility: Research Site
city: Mülheim an der Ruhr
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Naunhof
country: Germany
facility: Research Site
city: Neunkirchen
country: Germany
facility: Research Site
city: Neustadt In Sachsen
country: Germany
facility: Research Site
city: Nordhorn
country: Germany
facility: Research Site
city: Offenbach am Main
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Ostfildern
country: Germany
facility: Research Site
city: Passau
country: Germany
facility: Research Site
city: Plauen
country: Germany
facility: Research Site
city: Ratingen
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Singen
country: Germany
facility: Research Site
city: Spremberg
country: Germany
facility: Research Site
city: Stolberg
country: Germany
facility: Research Site
city: Stralsund
country: Germany
facility: Research Site
city: Sömmerda
country: Germany
facility: Research Site
city: Würselen
country: Germany
facility: Research Site
Study officials:
affiliation: OSP Göttingen - Gemeinschaftspraxis Dres. Meyer, Ammon, Metz und Müller
name: Michael Metz, Dr. med.
role: STUDY_CHAIR
References:
citation: Metz M, Semsek D, Rogmans G, Hutzschenreuter U, Fietz T, Harde J, Zacharias S, Hielscher C, Lorenz A, Zahn MO, Guth D, Liebers S, Berghorn M, Grebhardt S, Matillon CD, Egerer G, Potthoff K. Patient, nurse, and physician preferences: final results of the CONVENIENCE study evaluating pegfilgrastim prophylaxis via pre-filled syringe or on-body injector in cancer patients. Support Care Cancer. 2021 Nov;29(11):6633-6643. doi: 10.1007/s00520-021-06230-9. Epub 2021 May 6.