Clinic for Palliative Care, Medical Center, University of Freiburg D-79106 Freiburg (Baden-Württemberg) GermanyRekrutierend» Google-Maps Ansprechpartner: Gerhild Becker, Prof. Phone: +49 761 270 - 95412 E-Mail: gerhild.becker@uniklinik-freiburg.de» Ansprechpartner anzeigen
1. Feasibility of the study design (Time Frame - 12 months): Rates of patient recruitment per month, screening failures, drop-out from the trial.
2. Number of patients who show no relevant increase of nausea (Time Frame - day 1 to day 6): Number of patients who show no relevant increase of nausea after starting opioid therapy at any of the following 6 days. Nausea scores are assessed on an increasing 11-point numeric rating scale (NRS) from 0 to 10, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity according to the Edmonton Symptom Assessment Schedule (ESAS). Relevant is an increase on this NRS ≥1, which reflects the minimal clinically important difference (MCID) for nausea
Secondary outcome:
1. Complete response of OINV (Time Frame - day 1 to day 6): Complete response defined as no emetic episodes, no nausea, no rescue anti-emetic. Comparing Palonosetron treatment with placebo
2. Time to OINV (Time Frame - day 1 to day 6): Time to emetic episodes or nausea or rescue antiemetic after randomisation, comparing Palonosetron treatment with placebo
3. Nausea (Time Frame - day 1 to day 6): Occurrence and severity of nausea rated by the participants on a 11-point numeric rating scale (NRS), comparing Palonosetron treatment with placebo. Nausea scores are assessed on an increasing 11-point numerical scale from 0 to 10, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity according to the Edmonton Symptom Assessment Schedule (ESAS).
4. Vomiting (Time Frame - day 1 to day 6): Occurrence of vomiting, comparing Palonosetron treatment with placebo
5. Pain control (Time Frame - day 1 to day 6): Daily opioid intake and pain score rated by the participants on a 11-point numeric rating scale (NRS). Pain scores are assessed on an increasing 11-point numerical scale from 0 to 10, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity according to the Edmonton Symptom Assessment Schedule (ESAS)
6. Rescue anti-emetics (Time Frame - day 1 to day 6): The use of rescue anti-emetics, comparing Palonosetron treatment with placebo
7. Participant's burden by nausea, pain, constipation and headache (Time Frame - day 1 to day 6): Assessed by a questionnaire: Patients are asked to assign the burden of their symptoms to one of 4 categories: not at all, a little, strongly, extremely strongly
8. Severity of constipation (Time Frame - day1 and day 6): Stool consistency and frequency, bowel function index (BFI)
9. Symptom preferences (Time Frame - day1 and day 6): Patients were asked to rank 5 possible symptoms (tumor pain, nausea, vomiting, constipation, headache) from their most undesired to their most acceptable symptom. Rated by the participants at day 6 and compared to baseline.
10. Percentage of participants reporting any grade 3 adverse event (AE) or any serious adverse event (SAE) from patients from the time of the signed ICF to the end of the study. (Time Frame - day 1 to day 6): An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
11. Patient satisfaction with the study drug (Time Frame - day 6): Patients are asked to rate speed of action of the study drug received, the satisfaction with the overall control of nausea and emesis using 4 categories (very satisfied, satisfied, dissatisfied, very dissatisfied) and the and willingness to use the study drug again (yes, no, unknown). Rated by the participants at day 6.
