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Observational study of formulated rolapitant capsules as CINV prophylaxis in highly emetogenic chemotherapy protocols

Observational study of formulated rolapitant capsules as CINV prophylaxis in highly emetogenic chemotherapy protocols

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00030979
Enrollment
100
Registered
2022-12-27
Start date
2023-01-26
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

Influence of CINV prophylaxis (rolapitant, granisetron, dexamethasone) on quality of life in highly emetogenic chemotherapy protocols

Interventions

Group 1: Patients on highly emetogenic chemotherapy protocol receiving the antiemesis triple rolapitant, granisetron, and dexamethasone for CINV prophylaxis

Sponsors

Universitätsmedizin Mainz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients who understand and can read German - Willingness to participate in the study: declaration of consent to participate (documented by signature) and data collection - Patients of the hematology/oncology wards of the III Medical Clinic of the University Medical Center Mainz (M3 605 3A - D) - Use of a highly emetogenic chemotherapy protocol as first cycle or repeat cycle, especially cisplatin-containing chemotherapy protocols and conditioning protocols in stem cell transplant patients.

Exclusion criteria

Exclusion criteria: - Lack of capacity to consent and/or ability of the patient to give consent - No willingness to participate in the study

Design outcomes

Primary

MeasureTime frame
Completion of the FLIE questionnaire (after Lindley C) on days 1, 6 (and 13) of the chemotherapy protocol (influence of quality of life in intraindividual comparison, as well as comparison with data known from literature on aprepitant)

Secondary

MeasureTime frame
Review of assigned antiemetic prophylaxis via patient chart regarding correct assignment and proper administration, as well as review of whether additional antiemetics were given as on-demand medication during the course of the chemotherapy protocol

Countries

Germany

Contacts

Public ContactTim Hippchen

Universitätsmedizin Mainz

tim.hippchen@unimedizin-mainz.de+49 6131 17 4463

Outcome results

None listed

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