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Emesis Control Study in Non-Hodgkin Lymphoma Patients Receiving R-CHOP

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard anti-emetics in conjunction with R-CHOP
Sponsored by
Australasian Leukaemia and Lymphoma Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphoma, Non-Hodgkin focused on measuring Lymphoma, Non-Hodgkin, Emesis, Chemotherapy, Nausea, Vomiting, Aprepitant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically confirmed diagnosis of non Hodgkin's Lymphoma
  2. Newly diagnosed or relapsed patients who are chemotherapy-naïve or who have not received chemotherapy in the last 12 months. Pre-phase therapy with prednisolone and/or vincristine for < one week duration prior to commencement of cycle 1 of R-CHOP is permissible
  3. Intended to receive R-CHOP every 14 or 21 days for minimum 3 cycles with rituximab planned to be given with CHOP on day 1 or fractionated over days 1 and 21.
  4. Males and females, age 18 years or older
  5. Are reasonably expected to be able to complete the CINV tool
  6. Willing to complete assessments and tool as required for the study
  7. ECOG (Eastern Cooperative Oncology Group) performance status score of 2 or less
  8. Has provided written informed consent

Exclusion Criteria:

  1. Women who are pregnant or lactating.
  2. Previous adverse reaction to the standard anti-emetics proposed in the study
  3. Contraindications to the use of the anti-emetics included as standard of care in the study (e.g. cardiac, liver function)
  4. Participation in other therapeutic studies investigating CINV.
  5. Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study
  6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    R-CHOP and standard anti-emetics

    Arm Description

    This is a single arm study. All patients receive R-CHOP every 14 or 21 days for a minimum of 3 cycles. Standard anti-emetics will be used as follows: 5HT3 (5-Hydroxytryptamine 3) antagonists (ondansetron, granisetron or tropisetron) used as the local institutional standard of care will be permitted, although the preferential use of ondansetron or granisetron will be encouraged. Dexamethasone will not to be used as patients receive hydrocortisone and oral prednisolone in R-CHOP. In this study, the use of oral prednisolone on day 1 will be regarded as equivalent to dexamethasone. Prednisolone will be given PRIOR to the chemotherapy with the 5HT3 antagonist. Anti-emetics (metoclopramide, prochlorperazine and lorazepam) may be prescribed to be used 'as needed' for breakthrough emesis. Patients 'failing' the standard Chemotherapy Induced Nausea and Vomiting prophylactic regimen will be eligible to receive aprepitant (Days 1 to 3) for subsequent cycles.

    Outcomes

    Primary Outcome Measures

    Complete Response, Acute Phase (Day 1), Cycle 1
    The proportion of patients experiencing a complete response defined as no vomiting and no use of breakthrough medication in the acute phase (day 1: 0 - 24 hours) of the first cycle of R-CHOP chemotherapy
    Complete Response, Delayed Phase (Days 2 to 11), Cycle 1
    The proportion of patients experiencing a complete response defined as no vomiting and no use of breakthrough medication in the delayed phase (days 2 - 11 inclusive) of the first cycle of R-CHOP chemotherapy

    Secondary Outcome Measures

    Complete Response - Cycle 2 and beyond
    Complete response in the acute and delayed phases of each of cycles 2 and beyond of R-CHOP chemotherapy
    No Significant Nausea - Cycle 2 and beyond
    No significant nausea (defined as a nausea experience score of <2.5cm on a 0 - 10cm visual analogue scale) in the acute and delayed phases of each of cycles 2 and beyond of R-CHOP chemotherapy
    Failure of standard anti-emetic prophylaxis, Day 1 to Day 11, Cycle 1 and beyond
    Failure of standard anti-emetic prophylaxis in the acute and delayed phase of any one cycle of chemotherapy requiring aprepitant as secondary prophylaxis in subsequent cycles. Failure will be defined as the occurrence of any of the following either during or beyond cycle day 1: One or more episodes of vomiting One or more episodes of nausea requiring the use of 1 or more doses of breakthrough anti-emetics An episode of nausea requiring the use of breakthrough anti-emetics across multiple days An episode of nausea measuring > 2.5cm on a 0 - 10cm visual analogue scale Nausea and/or vomiting that in the clinicians opinion requires use of aprepitant in future cycles
    Frequency of common adverse events associated with anti-emetics
    Adverse Events (all grades) of the anti-emetic regimen in each cycle of R-CHOP chemotherapy
    Severity of common adverse events associated with anti-emetics
    Adverse Events (all grades) of the anti-emetic regimen in each cycle of R-CHOP chemotherapy

    Full Information

    First Posted
    April 24, 2013
    Last Updated
    April 28, 2013
    Sponsor
    Australasian Leukaemia and Lymphoma Group
    Collaborators
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01843868
    Brief Title
    Emesis Control Study in Non-Hodgkin Lymphoma Patients Receiving R-CHOP
    Official Title
    A Single Arm Study to Evaluate the Control of Chemotherapy Induced Nausea and Vomiting in Non-Hodgkin Lymphoma Patients Receiving R-CHOP.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Australasian Leukaemia and Lymphoma Group
    Collaborators
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma, Non-Hodgkin
    Keywords
    Lymphoma, Non-Hodgkin, Emesis, Chemotherapy, Nausea, Vomiting, Aprepitant

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    R-CHOP and standard anti-emetics
    Arm Type
    Other
    Arm Description
    This is a single arm study. All patients receive R-CHOP every 14 or 21 days for a minimum of 3 cycles. Standard anti-emetics will be used as follows: 5HT3 (5-Hydroxytryptamine 3) antagonists (ondansetron, granisetron or tropisetron) used as the local institutional standard of care will be permitted, although the preferential use of ondansetron or granisetron will be encouraged. Dexamethasone will not to be used as patients receive hydrocortisone and oral prednisolone in R-CHOP. In this study, the use of oral prednisolone on day 1 will be regarded as equivalent to dexamethasone. Prednisolone will be given PRIOR to the chemotherapy with the 5HT3 antagonist. Anti-emetics (metoclopramide, prochlorperazine and lorazepam) may be prescribed to be used 'as needed' for breakthrough emesis. Patients 'failing' the standard Chemotherapy Induced Nausea and Vomiting prophylactic regimen will be eligible to receive aprepitant (Days 1 to 3) for subsequent cycles.
    Intervention Type
    Drug
    Intervention Name(s)
    Standard anti-emetics in conjunction with R-CHOP
    Other Intervention Name(s)
    R-CHOP:, rituximab, doxorubicin, vincristine, cyclophosphamide, prednisolone, Anti-emetics:, ondansetron, granisetron, tropisetron, palonosetron, metoclopramide, prochlorperazine, lorazepam, aprepitant
    Primary Outcome Measure Information:
    Title
    Complete Response, Acute Phase (Day 1), Cycle 1
    Description
    The proportion of patients experiencing a complete response defined as no vomiting and no use of breakthrough medication in the acute phase (day 1: 0 - 24 hours) of the first cycle of R-CHOP chemotherapy
    Time Frame
    Day 1
    Title
    Complete Response, Delayed Phase (Days 2 to 11), Cycle 1
    Description
    The proportion of patients experiencing a complete response defined as no vomiting and no use of breakthrough medication in the delayed phase (days 2 - 11 inclusive) of the first cycle of R-CHOP chemotherapy
    Time Frame
    Days 2 to 11
    Secondary Outcome Measure Information:
    Title
    Complete Response - Cycle 2 and beyond
    Description
    Complete response in the acute and delayed phases of each of cycles 2 and beyond of R-CHOP chemotherapy
    Time Frame
    Day 1 to Day 11
    Title
    No Significant Nausea - Cycle 2 and beyond
    Description
    No significant nausea (defined as a nausea experience score of <2.5cm on a 0 - 10cm visual analogue scale) in the acute and delayed phases of each of cycles 2 and beyond of R-CHOP chemotherapy
    Time Frame
    Day 1 to Day 11
    Title
    Failure of standard anti-emetic prophylaxis, Day 1 to Day 11, Cycle 1 and beyond
    Description
    Failure of standard anti-emetic prophylaxis in the acute and delayed phase of any one cycle of chemotherapy requiring aprepitant as secondary prophylaxis in subsequent cycles. Failure will be defined as the occurrence of any of the following either during or beyond cycle day 1: One or more episodes of vomiting One or more episodes of nausea requiring the use of 1 or more doses of breakthrough anti-emetics An episode of nausea requiring the use of breakthrough anti-emetics across multiple days An episode of nausea measuring > 2.5cm on a 0 - 10cm visual analogue scale Nausea and/or vomiting that in the clinicians opinion requires use of aprepitant in future cycles
    Time Frame
    Day 1 to Day 11
    Title
    Frequency of common adverse events associated with anti-emetics
    Description
    Adverse Events (all grades) of the anti-emetic regimen in each cycle of R-CHOP chemotherapy
    Time Frame
    Day 1 to Day 11
    Title
    Severity of common adverse events associated with anti-emetics
    Description
    Adverse Events (all grades) of the anti-emetic regimen in each cycle of R-CHOP chemotherapy
    Time Frame
    Day 1 to Day 11

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically confirmed diagnosis of non Hodgkin's Lymphoma Newly diagnosed or relapsed patients who are chemotherapy-naïve or who have not received chemotherapy in the last 12 months. Pre-phase therapy with prednisolone and/or vincristine for < one week duration prior to commencement of cycle 1 of R-CHOP is permissible Intended to receive R-CHOP every 14 or 21 days for minimum 3 cycles with rituximab planned to be given with CHOP on day 1 or fractionated over days 1 and 21. Males and females, age 18 years or older Are reasonably expected to be able to complete the CINV tool Willing to complete assessments and tool as required for the study ECOG (Eastern Cooperative Oncology Group) performance status score of 2 or less Has provided written informed consent Exclusion Criteria: Women who are pregnant or lactating. Previous adverse reaction to the standard anti-emetics proposed in the study Contraindications to the use of the anti-emetics included as standard of care in the study (e.g. cardiac, liver function) Participation in other therapeutic studies investigating CINV. Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Juliana Di Iulio
    Phone
    +61 3 9656 3786
    Email
    Juliana.DiIulio@petermac.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew Grigg, Professor
    Organizational Affiliation
    Director of Clinical Haematology, Austin Hospital, Australia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Emesis Control Study in Non-Hodgkin Lymphoma Patients Receiving R-CHOP

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