Patients with cancer receiving moderately emetogenic non-AC-based chemotherapy MedDRA version: 20.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: dexamethasone PCH
Product Name: dexamethasone
Pharmaceutical Form: Tablet
INN or Proposed INN: Dexamethasone Sodium Phosphate
CAS Number: 50-02-2
Concentration unit: mg milligram(s)
Conc
Sponsors
VU University Medical Center Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient has been diagnosed with histologically or cytologically confirmed solid cancer • Starting with first cycle of chemotherapy of moderate emetogenic risk, which does not include a combination of anthracycline plus cyclophosphamide • Age = 18 • WHO = 1 (attachment 1) • Patient is able to understand and speak Dutch Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: • Patient with nausea and/or vomiting in 48 hours before start of chemotherapy treatment • Patient submitted to concomitant radiotherapy or submitted to radiotherapy 15 days before start of chemotherapy or planned to receive radiotherapy during 8 days after administration of chemotherapy • Patient with concomitant severe comorbidy, such as: o Intestinal obstruction o Active peptic ulcer o Hypercalcemia o Uncontrolled diabetes mellitus o Pheochromocytoma o Tardive dyskinesia o Epilepsia o Active infective diseases o Brain – or leptomeningeal metastases o Psychiatrical disorders o Parkinsonism • Current use of corticosteroids (similar to prednisone = 10 milligrams per day) • Current alcohol abuse • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether metoclopramide and Aloxi (palonosetron) prophylactic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed CINV in cancer patients receiving non-AC-based MEC. ;Secondary Objective: The secondary objectives are: • To evaluate the side effects of metoclopramide, dexamethasone and palonosetron. • To evaluate the impact of metoclopramide, dexamethasone and palonosetron on QoL. ;Primary end point(s): • Primary efficacy endpoint: the proportion of patients reporting complete response during the overall 24 to 160 hours after initiation of the first cycle of MEC. Complete response is defined as no vomiting and nausea and no use of rescue medication. A diary will be used to document the date and time of any emetic episodes and use of rescue medication, as well as daily nausea ratings. • Primary tolerability endpoint: the proportion of patients with minimal or no antiemetic therapy-related side effects according to the DSQ questionnaire, the AIMS and Palonosetron questionnaire during the first cycle of MEC.;Timepoint(s) of evaluation of this end point: Day eight after start of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Secondary efficacy endpoint: the proportion of patients with minimal or no impact on daily life of CINV according to the FLIE questionnaire during the first cycle of MEC. • Secondary tolerability endpoint: the proportion of patients with minimal or no impact on daily life of antiemetic therapy-related side effects according to the EORTC QLQ C-30 during the first cycle of chemotherapy.;Timepoint(s) of evaluation of this end point: Day eight after start of chemotherapy | — |
Countries
Netherlands
Contacts
Public ContactHenk M.W. Verheul
VU University Medical Center Amsterdam
Outcome results
None listed