Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-28 @ 9:14 PM
Study NCT ID:
NCT00415103
Status:
COMPLETED
Last Update Posted:
2009-09-18
First Post:
2006-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AMENO-2: Aprepitant Plus Palonosetron Versus Granisetron in the Prevention of Nausea and the Emesis Induced by Chemotherapy in Patients Treated With Haematopoietic Progenitors
Sponsor:
PETHEMA Foundation
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMENO-2
Brief Summary:
The purpose of this trial is to 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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: