In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antiemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed CINV induced by non-AC based…
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Health condition
alle vormen van solide tumoren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 Aloxi questionnaire during the first cycle of MEC.
Primary cost-effectiveness endpoint: total antiemetic medication costs per
treatment regimen during the first cycle of MEC. A diary will be used to
document the use of antiemetics and rescue medication. Total medication costs
will be calculated from this.
Secondary outcome
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.
Background summary
Although significant progress has been made with the development of a number of
effective and well-tolerated antiemetic treatments, chemotherapy-induced nausea
and vomiting (CINV) remains among the most distressing and feared side-effects
of cancer treatment. Recently, chemotherapeutic agents have been classified
into four risk categories of emesis: high (> 90%, HEC), moderate (30%-90%,
MEC), low (10%-30%), and minimal (< 10%). International guidelines recommend
monotherapy multi-day oral dexamethasone as the preferred standard prophylaxis
for delayed CINV in patients receiving MEC.
These international guidelines are not supported by studies in which dose and
schedule of dexamethasone have been determined by formal testing. In addition,
no studies have been performed comparing its efficacy with metoclopramide or
palonosetron (aloxi) in this setting. Moreover, the administration of
dexamethasone is associated with a range of side effects, which increase when
administered as part of multi-day antiemetic regimens. The use of dexamethasone
as an antiemetic may have a substantial deleterious effect on Quality of Life
(QoL) and therefore its benefits should be evaluated when used with MEC.
Study objective
In this phase III non-inferiority trial, the aim is to evaluate whether
metoclopramide and palonosetron prophylactic antiemetic treatment are
non-inferior to dexamethasone with regard to its efficacy to prevent delayed
CINV induced by non-AC based MEC. In addition it will be studied whether
metoclopramide and palon prophylactic antiemetic treatment have a significantly
lower incidence of side effects and a less negative impact on QoL than
dexamethasone. The relative cost-effectiveness of the different antiemetic
regimens will also be evaluated.
Study design
Open label, multicenter, ranomised, phase III, non-inferiority study
Intervention
Dexamethasone (8 mg/day) should be taken twice daily, as two 4 mg tablets, with
a sufficient amount of water during meals, on days 2 and 3.
Metoclopramide (30-60 mg/day) should be taken three-times, as single 10 mg
tablets with a sufficient amount of water between meals and spread out during
the day, on days 2 and 3. Metoclopramide can also be taken as a single 20 mg
suppository, three times daily.
Palonosetron is administered as a single dose bolus of 125 mg on day 1, 30
minutes before chemotherapy is administered.
Study burden and risks
The burden and risks for the participants of this study are low: no extra blood
samples, no extra visits or examinations are planned. A diary and seven
questionnaires need to be filled in, including four self-administered
questionnaires. Time of follow up is short: the end-of-treatment visit is
scheduled on day 8 after initiation of the first cycle of MEC. Patients who
successfully complete the first cycle are eligible to continue into the second
cycle of MEC, with similar burden and risks.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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
* Patient is able to understand and speak Dutch
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-004446-17-NL |
| CCMO | NL38215.029.11 |