Ignite Creation Date:
2024-05-06 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03606369
Status:
UNKNOWN
Last Update Posted:
2018-07-30
First Post:
2018-07-03
Brief Title:
Effectiveness and Quality of Life Analysis of Palonosetron Against Ondansetron Combined With Dexamethasone and Fosaprepitant in Prevention of Acute and Delayed Emesis Associated to Chemotherapy Moderate and Highly Emetogenic in Breast Cancer
Sponsor:
Instituto Nacional de Cancerologia de Mexico
Organization:
Instituto Nacional de Cancerologia de Mexico
Study Overview
Official Title:
Effectiveness and Quality of Life Analysis of Palonosetron Against Ondansetron Combined With Dexamethasone and Fosaprepitant in Prevention of Acute and Delayed Emesis Associated to Chemotherapy Moderate and Highly Emetogenic in Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Nausea and vomiting are common complications on the chemotherapy CT and can affect the quality of life QoL of the patients If not treated adequately it can produce other problems such as dehydration weight loss fatigue and even can induce the non-compliance of the treatment In extreme cases it can put the patient s life at risk There are various antiemetic treatments that vary both in cost and effectiveness It s important to determine which are the strategies that are most effective and can improve the QoL of the patients
Methodology
The analysis will be done in patients who receive adjuvant and neoadjuvant chemotherapy and that have not received previously chemotherapy or radiotherapy they will be stratified according to the emetogenic potential of the CT They were given a diary of symptoms to register any discomfort suffered after receiving their treatment and also a quality of life questionnaire was applied previous to their first cycle and previous to their second cycle
The patients were divided in two groups receiving either A scheme palonosetron or B scheme ondansetron in combination with dexamethasone and fosaprepitant for prevention of early emesis and Dexamethasone to group A or Dexamethasone metoclopramide to group B for prevention of delayed emesis As well It was analyzed the three most prevalent single nucleotide polymorphisms SNPs on gene ABCB1 using PCR
The aim of this study is to evaluate the efficacy and quality of life provided by the 2 regimes noted above based on Mexican population so the results obtained can be applied widely in our country
Methodology
The analysis will be done in patients who receive adjuvant and neoadjuvant chemotherapy and that have not received previously chemotherapy or radiotherapy they will be stratified according to the emetogenic potential of the CT They were given a diary of symptoms to register any discomfort suffered after receiving their treatment and also a quality of life questionnaire was applied previous to their first cycle and previous to their second cycle
The patients were divided in two groups receiving either A scheme palonosetron or B scheme ondansetron in combination with dexamethasone and fosaprepitant for prevention of early emesis and Dexamethasone to group A or Dexamethasone metoclopramide to group B for prevention of delayed emesis As well It was analyzed the three most prevalent single nucleotide polymorphisms SNPs on gene ABCB1 using PCR
The aim of this study is to evaluate the efficacy and quality of life provided by the 2 regimes noted above based on Mexican population so the results obtained can be applied widely in our country
Detailed Description:
Nausea and vomiting are common complications on the chemotherapy CT and can affect the quality of life QoL of the patients If not treated adequately Nausea and vomiting can produce other problems such as dehydration weight loss fatigue and even can induce the non-compliance of the treatment In extreme cases it can put the patient s life at risk There are various antiemetic treatments that vary both in cost and effectiveness It s important to determine which are the strategies that are most effective and can improve the QoL of the patients
Methodology
Effectiveness and quality of life analysis of patients with breast cancer that will receive adjuvant and neoadjuvant chemotherapy highly and moderately emetic chemotherapy adriamycin and cyclophosphamide AC docetaxel and carboplatin TC docetaxel carboplatin and trastuzumab THC there will only be consider those patients that are candidates to receive CT for the first time and should have central venous access There will be excluded patients that had received previously any kind of chemotherapy or radiotherapy The follow-up will exclusively be done during the first cycle of CT Patients will be stratified according to the emetogenic potential of the CT regimen ad not by the clinical stage or the histologic type of the tumor
To keep a follow-up of the patient there will be provided symptomatic diaries where the patient can register any discomfort suffered after receiving their treatment Along with this there will be applied quality of life questionnaires one previous to the CT and one previous to the second cycle
There a proposed two regimes on antiemetic treatment The randomization is as follows
Group A Early emesis Palonosetron 025 mg IV Dexamethasone 12 mg IV Fosaprepitant 150 mg IV Delayed emesis Dexamethasone 8 mg orally on days 2 3 and 4
Group B Early Emesis Ondansetron 16 mg IV Dexamethasone 12 mg IV Fosaprepitant 150 mg IV Delayed Emesis Metoclopramide 10 mg orally every 6 hours Dexamethasone 8 mg orally every 24 hrs
Considering the absence of at least one event of nausea and vomiting as a measure of effectiveness it will be calculated the effectiveness ratio as well as the QoL questionnaires before and after the first chemotherapy
Finally previously to the application of the treatment there will be obtained a peripheral blood sample for its analysis on translational medicine laboratory There will be a process of extraction of Deoxyribonucleic Acid accordingly to the guides and the sample will be analyzed by a protein chain reaction PCR to detect the three most prevalent polymorphisms SNPson gene ABCB1
H0 There s no difference in cost - effectiveness ratio in antiemetic therapy acute and delayed between A and B schemes
H1 Scheme A is superior than scheme B in 10 for prevention of acute nausea and vomiting and 6 in delayed nausea and vomiting
Applications
The guides that are actually used for the antiemetic treatments are based in non Mexican populations With this study it is expected to design an effective strategy that can be applied in mexican population
Methodology
Effectiveness and quality of life analysis of patients with breast cancer that will receive adjuvant and neoadjuvant chemotherapy highly and moderately emetic chemotherapy adriamycin and cyclophosphamide AC docetaxel and carboplatin TC docetaxel carboplatin and trastuzumab THC there will only be consider those patients that are candidates to receive CT for the first time and should have central venous access There will be excluded patients that had received previously any kind of chemotherapy or radiotherapy The follow-up will exclusively be done during the first cycle of CT Patients will be stratified according to the emetogenic potential of the CT regimen ad not by the clinical stage or the histologic type of the tumor
To keep a follow-up of the patient there will be provided symptomatic diaries where the patient can register any discomfort suffered after receiving their treatment Along with this there will be applied quality of life questionnaires one previous to the CT and one previous to the second cycle
There a proposed two regimes on antiemetic treatment The randomization is as follows
Group A Early emesis Palonosetron 025 mg IV Dexamethasone 12 mg IV Fosaprepitant 150 mg IV Delayed emesis Dexamethasone 8 mg orally on days 2 3 and 4
Group B Early Emesis Ondansetron 16 mg IV Dexamethasone 12 mg IV Fosaprepitant 150 mg IV Delayed Emesis Metoclopramide 10 mg orally every 6 hours Dexamethasone 8 mg orally every 24 hrs
Considering the absence of at least one event of nausea and vomiting as a measure of effectiveness it will be calculated the effectiveness ratio as well as the QoL questionnaires before and after the first chemotherapy
Finally previously to the application of the treatment there will be obtained a peripheral blood sample for its analysis on translational medicine laboratory There will be a process of extraction of Deoxyribonucleic Acid accordingly to the guides and the sample will be analyzed by a protein chain reaction PCR to detect the three most prevalent polymorphisms SNPson gene ABCB1
H0 There s no difference in cost - effectiveness ratio in antiemetic therapy acute and delayed between A and B schemes
H1 Scheme A is superior than scheme B in 10 for prevention of acute nausea and vomiting and 6 in delayed nausea and vomiting
Applications
The guides that are actually used for the antiemetic treatments are based in non Mexican populations With this study it is expected to design an effective strategy that can be applied in mexican population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None