Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
Study NCT ID:
NCT01843868
Status:
WITHDRAWN
Last Update Posted:
2024-08-07
First Post:
2013-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emesis Control Study in Non-Hodgkin Lymphoma Patients Receiving R-CHOP
Sponsor:
Australasian Leukaemia and Lymphoma Group
Organization:
Study Overview
Official Title:
A Single Arm Study to Evaluate the Control of Chemotherapy Induced Nausea and Vomiting in Non-Hodgkin Lymphoma Patients Receiving R-CHOP.
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study halted prematurely, prior to enrollment of first participant due to protracted logistical and subsequent funding matters.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The incidence and severity of chemotherapy-induced nausea and vomiting (CINV) in patients receiving R-CHOP chemotherapy for in non-Hodgkin's lymphoma is not well documented. The contribution of prednisolone to CINV control in the R-CHOP regimen is also unclear.
This study aims to evaluate the overall effectiveness of antiemetic control using a standardised 5HT3 (5-Hydroxytryptamine 3) antagonist-containing regimen (e.g. ondansetron) in a heterogeneous group of patients receiving R-CHOP chemotherapy (Rituximab Doxorubicin Vincristine Cyclophosphamide Prednisolone).
This study aims to evaluate the overall effectiveness of antiemetic control using a standardised 5HT3 (5-Hydroxytryptamine 3) antagonist-containing regimen (e.g. ondansetron) in a heterogeneous group of patients receiving R-CHOP chemotherapy (Rituximab Doxorubicin Vincristine Cyclophosphamide Prednisolone).
Detailed Description:
The aim of this study will be to investigate the incidence and severity of CINV in patients receiving R-CHOP for the treatment of non-Hodgkin lymphoma and standardised antiemetic prophylaxis.
The study hypothesises that the control of delayed nausea and emesis is suboptimal in a proportion of patients receiving R-CHOP regimens and that delayed CINV is not prevented by use of 5HT3 antagonists beyond the first day of use post-chemotherapy administration.
Participating institutions will prospectively collect data on the incidence of CINV, the severity of CINV, the use of break through/rescue medication for episodes of CINV uncontrolled by prescribed regular antiemetics, the effectiveness of additional measures used when previous CINV control has been inadequate (for example the use of aprepitant as an additional measure in subsequent cycles) and the major side-effects likely to be related to the antiemetics.
The analysis of these results will determine the incidence and severity of CINV in patients receiving R-CHOP and the effectiveness of the prescribed antiemetic regimens. Analysis will also determine if the control and incidence of CINV is a significant problem in defined subgroups of patients receiving R-CHOP and could inform the design of future research (or an extension of the current protocol) in this area. Sub groups for investigation will include patients with advanced disease, those with abdominal involvement, those receiving R-CHOP every 14 days versus every 21 days (R-CHOP14 versus R-CHOP21), those receiving 6 or 8 treatment cycles of R-CHOP, older patients, younger females etc. A potential randomised study evaluating the role of aprepitant could be contemplated in high risk groups.
The study hypothesises that the control of delayed nausea and emesis is suboptimal in a proportion of patients receiving R-CHOP regimens and that delayed CINV is not prevented by use of 5HT3 antagonists beyond the first day of use post-chemotherapy administration.
Participating institutions will prospectively collect data on the incidence of CINV, the severity of CINV, the use of break through/rescue medication for episodes of CINV uncontrolled by prescribed regular antiemetics, the effectiveness of additional measures used when previous CINV control has been inadequate (for example the use of aprepitant as an additional measure in subsequent cycles) and the major side-effects likely to be related to the antiemetics.
The analysis of these results will determine the incidence and severity of CINV in patients receiving R-CHOP and the effectiveness of the prescribed antiemetic regimens. Analysis will also determine if the control and incidence of CINV is a significant problem in defined subgroups of patients receiving R-CHOP and could inform the design of future research (or an extension of the current protocol) in this area. Sub groups for investigation will include patients with advanced disease, those with abdominal involvement, those receiving R-CHOP every 14 days versus every 21 days (R-CHOP14 versus R-CHOP21), those receiving 6 or 8 treatment cycles of R-CHOP, older patients, younger females etc. A potential randomised study evaluating the role of aprepitant could be contemplated in high risk groups.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ACTRN12611001269921 | REGISTRY | Australian New Zealand Clinical Trials Registry | View |