Non-intervention study to the capture of the quality of life with the adult patients who receive Akynzeo to the prevention from nausea and vomiting caused by highly or moderate emetogenic chemotherapy

Non-intervention study to the capture of the quality of life with the adult patients who receive Akynzeo to the prevention from nausea and vomiting caused by highly or moderate emetogenic chemotherapy - AkyPro NIS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00009316

Enrollment

2500

Registered

2015-10-20

Start date

2015-10-07

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chemotherapy induced nausea and vomiting C00-C97 R11

Interventions

Group 1: The patients will be observed and documented for a period of 3 chemotherapeutic cycles. Data about the quality of life will be collected by using the FLIE-questionnaire (standardised question

the capsule needs to be swallowed in toto. Dosing regimen: one capsule of 300 mg/0,5 mg needs to be taken about one hour before beginning of each chemotherapy cycle (always on day 1 of each cycle).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Signed patient consent form • Age: = 18 Years • 1- or 2-day chemotherapy, high or moderate emetogen • anti-emetic prevention with Akynzeo® according to the summary of product characteristics

Exclusion criteria

Exclusion criteria: • Patients without chemotherapy • radiotherapy alone • brain tumour, symptomatic brain metastases • anticipatory nausea and vomiting • not chemotherapy-induced nausea and vomiting on the basis of other disorders or drugs • chemotherapies that last more than 2 days within a chemotherapy cycle • pregnancy • hypersensitivity to the active substances, excipient or other constituent materials of Akynzeo®

Design outcomes

Primary

Measure	Time frame
quality of life by means of FLIE questionnaires (The recording of the questionnaires by the study participants is done respectively on day 5 or 6 after medication with Akynzeo(R). The questionnaires will be filled in on three consecutive medications with Akynzeo(R).)	—

Secondary

Measure	Time frame
• complete response (no vomiting, no rescue medication) by eCRF & Patient Diary • kind of additional medication • safety data and AE	—

Countries

Germany

Contacts

Public ContactAnna Merk

ONKODATAMED GmbH

anna.merk@onkodatamed.de03342 4268910

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026