AMENO-2: Fase IV Study, National, Multiple Centers, Competitive, Randomized, Double Blind, Controlled With Parallel Groups to Determinate the Security, Tolerability and Efficacy of Aprepitant Plus Palonosetron Versus Granisetron in the Prevention of Nausea and the Emesis Induced by Chemotherapy in Patients Treated With Haematopoietic Progenitors
Patients with haematopoietic cancer (as leukaemia and lymphomas) that are treated with high
doses of intense chemotherapy for the haematopoietic progenitors transplant experiment
intense nausea and emesis related to this chemotherapy treatment.
The introduction of regimens with antagonist of 5HT3 receptors (ondansetron, tropisetron,
granisetron) seems to have reduced the magnitude of the problem in the first 24 hours after
the beginning of the chemotherapy. However, in spite of the use of these drugs, it is very
frequency to observe intense nausea and emesis induced by chemotherapy especially in the
latest period (after 24 h).
MASCC guides establish that It is not possible to give firm recommendations in the
prevention of the NVIQ for these patients. Currently, the treatment of this problem in
patients that go through a total body irradiation is made with antagonist of 5HT3 receptors
with or without Dexamethasone.
There is neither recommendation regarding the antiemetic prophylaxis in chemotherapy
treatments with high emetogenic power of several days duration. However, there is
controversy about the use of high doses of steroids to avoid the latest emesis in transplant
patients ( because of the high doses of steroids, Its continuous use during several days in
this clinical situation and because of the possible worsening of the immunodeficiency
inherent to the oncohematology illness/the previous chemotherapy treatment received by the
patient). In patients that go trough a haematopoietic progenitor's transplant, many teams
prefer to avoid the use of steroids. Main clinical guides do not offer firm recommendations
regarding antiemetic prophylaxis protocols in the TPH and antagonists of 5-HT3 receptors are
commonly used in practice.
AMENO-1 study demonstrated that the incidence of NVIQ is high even with an anti-5HT3 daily
prevention (experimenting vomits or requiring rescue treatment for 81% of the TPH
receptors), this significantly ameliorated their quality of life.
Currently, there are new drugs with new action mechanisms and a probable synergy between
them that increase control of the NVIQ out of the transplant field. For that reason we have
designed a study with the purpose of evaluating whether these new drugs ameliorate the
control that we currently have of NVIQ (which is far from optimal).
To avoid differences in terms of posology regimes, granisetron will be used as the common
treatment with one daily dose of 3mg/day. The new experimental regime that we propose
includes two newly commercialized drugs with complementary and different mechanisms of
action that have demonstrated their efficacy and their security in the very emetogenic
chemotherapy administrated only one day: aprepitant and palonosetron.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Determinate the security, tolerability and efficacy of aprepitant plus palonosetron versus granisetron in the prevention of nausea and emesis induced by chemotherapy in patients treated with haematopoietic progenitors transplant
López Javier, Dr
Hospital Ramón y Cajal
Spain: Ministry of Health