Observational study of formulated rolapitant capsules as CINV prophylaxis in highly emetogenic chemotherapy protocols
Organizational Data
- DRKS-ID:
- DRKS00030979
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2022-12-27
- Last update in DRKS:
- 2024-04-02
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
The submitted observational study is intended to test the influence of the patients' quality of life after taking the quality-assured formulation of Rolapitant capsules 180 mg for the prophylaxis of chemoinduced nausea and vomiting (CINV) by means of a questionnaire (functional living index emesis according to Lindley C). The questionnaires will be evaluated intraindividually comparatively and compared with literature data on the finished drugs Varuby® and Emend®. By using rolapitant instead of another representative of the NK1 antagonists, the interaction rate with other drugs can be reduced and due to the long half-life of the active ingredient, a single dose on day 1 of the chemotherapy cycle is possible. In addition, the stability of the capsules will be verified by quantitative HPLC analysis. There are no additional risks for the patients by participating in the study. The study duration for the individual patient is expected to be from enrollment in the study to a maximum of day 13 of the respective chemotherapy cycle. The study is being conducted in cooperation between the pharmacy and the III Medical Clinic of the University Medical Center Mainz.
Health condition or problem studied
- Free text:
- Influence of CINV prophylaxis (rolapitant, granisetron, dexamethasone) on quality of life in highly emetogenic chemotherapy protocols
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Patients on highly emetogenic chemotherapy protocol receiving the antiemesis triple rolapitant, granisetron, and dexamethasone for CINV prophylaxis
Endpoints
- Primary outcome:
- 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 outcome:
- 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
Study Design
- Purpose:
- Supportive care
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Longitudinal study
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsmedizin Mainz Mainz
Recruitment period and number of participants
- Planned study start date:
- 2023-01-01
- Actual study start date:
- 2023-01-26
- Planned study completion date:
- 2023-12-31
- Actual Study Completion Date:
- 2024-01-31
- Target Sample Size:
- 100
- Final Sample Size:
- 92
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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
- Lack of capacity to consent and/or ability of the patient to give consent - No willingness to participate in the study
Addresses
Primary Sponsor
- Address:
- Universitätsmedizin MainzLangenbeckstraße 155131 MainzGermany
- Telephone:
- +49 6131 17 4463
- Fax:
- +49 6131 17 2262
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsmedizin MainzTim HippchenLangenbeckstraße 155131 MainzGermany
- Telephone:
- +49 6131 17 4463
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsmedizin MainzTim HippchenLangenbeckstraße 155131 MainzGermany
- Telephone:
- +49 6131 17 4463
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsmedizin MainzProf. Dr. rer. nat. Irene KrämerLangenbeckstraße 155131 MainzGermany
- Telephone:
- +49 6131 17 7209
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsmedizin Mainz55131 MainzGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission bei der Landesärztekammer Rheinland-PfalzDeutschhausplatz 355116 MainzGermany
- Telephone:
- +49-6131-288220
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-10-07
- Ethics committee number:
- 2022-16762-prospektiv, erstvotierend
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-11-30
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry