Lymphoma, Non-HodgkinNCT01843868
Emesis Control Study in Non-Hodgkin Lymphoma Patients Receiving R-CHOP
A study testing Standard anti-emetics in conjunction with R-CHOP in people with Lymphoma, Non-Hodgkin, run by Australasian Leukaemia and Lymphoma Group.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Standard anti-emetics in conjunction with R-CHOP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: A Single Arm Study to Evaluate the Control of Chemotherapy Induced Nausea and Vomiting in Non-Hodgkin Lymphoma Patients Receiving R-CHOP.
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).
Read the 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.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Standard anti-emetics in conjunction with R-CHOP
- Keywords
- Lymphoma, Non-Hodgkin, Emesis, Chemotherapy, Nausea, Vomiting, Aprepitant
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard anti-emetics in conjunction with R-CHOPDrug
Also called R-CHOP:, rituximab, doxorubicin, vincristine
| Study group | Role | What they receive |
|---|---|---|
| R-CHOP and standard anti-emetics | Other | 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. Receives: Drug: Standard anti-emetics in conjunction with R-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
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
Measured: Days 2 to 11
Secondary outcomes (5)
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
Measured: Day 1 to Day 11
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
Measured: Day 1 to Day 11
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
Measured: Day 1 to Day 11
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
Measured: Day 1 to Day 11
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
Measured: Day 1 to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startJan 2012 (estimated)
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: Study halted prematurely, prior to enrollment of first participant due to protracted logistical and subsequent funding matters.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australasian Leukaemia and Lymphoma Group
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Andrew Grigg, Professor, Principal investigator, Director of Clinical Haematology, Austin Hospital, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843868
- Sponsor's protocol ID
- ALLG SC03
- Other IDs
- ACTRN12611001269921
- Status last verified
- Aug 2024
- First submitted
- 24 Apr 2013
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Study to Evaluate the Control of Chemotherapy Induced Nausea and Vomiting in Non-Hodgkin Lymphoma Patients Receiving R-CHOP.
- ClinicalTrials.gov ID
- NCT01843868
- Acronym / sponsor ID
- ALLG SC03
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- Lymphoma, Non-Hodgkin, Emesis, Chemotherapy, Nausea, Vomiting, Aprepitant
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant due to protracted logistical and subsequent funding matters.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Australasian Leukaemia and Lymphoma GroupUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2012 (estimated)
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 1 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-CHOP and standard anti-emetics | Other | Drug: Standard anti-emetics in conjunction with R-CHOPThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard anti-emetics in conjunction with R-CHOPAlso: R-CHOP:, rituximab, doxorubicin, vincristine | Drug | R-CHOP and standard anti-emetics |
Primary outcome
Complete Response, Acute Phase (Day 1), Cycle 1
Time frame: Day 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
Time frame: Days 2 to 11
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
5 secondary outcomes
Complete Response - Cycle 2 and beyond
Time frame: Day 1 to Day 11
No Significant Nausea - Cycle 2 and beyond
Time frame: Day 1 to Day 11
Failure of standard anti-emetic prophylaxis, Day 1 to Day 11, Cycle 1 and beyond
Time frame: Day 1 to Day 11
Frequency of common adverse events associated with anti-emetics
Time frame: Day 1 to Day 11
Severity of common adverse events associated with anti-emetics
Time frame: Day 1 to Day 11
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Grigg, Professor principal investigator
Director of Clinical Haematology, Austin Hospital, Australia
Questions about this trial
What is this clinical trial studying?
A study testing Standard anti-emetics in conjunction with R-CHOP in people with Lymphoma, Non-Hodgkin, run by Australasian Leukaemia and Lymphoma Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response, Acute Phase (Day 1), Cycle 1 (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.