Clinical trial · Interventional
Emesis Control Study in Non-Hodgkin Lymphoma Patients Receiving R-CHOP
A Single Arm Study to Evaluate the Control of Chemotherapy Induced Nausea and Vomiting in Non-Hodgkin Lymphoma Patients Receiving R-CHOP.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study halted prematurely, prior to enrollment of first participant due to protracted logistical and subsequent funding matters.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard anti-emetics in conjunction with R-CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- R-CHOP and standard anti-emetics
- 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.
- interventionNames
- Drug: Standard anti-emetics in conjunction with R-CHOP
Primary outcomes (2)
- measure
- Complete Response, Acute Phase (Day 1), Cycle 1
- timeFrame
- Day 1
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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