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

NCT01843868 | Withdrawn DMC

• 2 other identifiers: ALLG SC03ACTRN12611001269921
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Lymphoma, Non-Hodgkin

Keywords

Lymphoma; Non-Hodgkin; Emesis; Chemotherapy; Nausea; Vomiting; Aprepitant

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Days 2 to 11

Secondary Outcomes (5)

• Complete Response - Cycle 2 and beyond

  Day 1 to Day 11

• No Significant Nausea - Cycle 2 and beyond

  Day 1 to Day 11

• Failure of standard anti-emetic prophylaxis, Day 1 to Day 11, Cycle 1 and beyond

  Day 1 to Day 11

• Frequency of common adverse events associated with anti-emetics

  Day 1 to Day 11

• Severity of common adverse events associated with anti-emetics

  Day 1 to Day 11

Study Arms (1)

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.

Drug: Standard anti-emetics in conjunction with R-CHOP

Interventions

Standard anti-emetics in conjunction with R-CHOP DRUG

Also known as: R-CHOP:, rituximab, doxorubicin, vincristine, cyclophosphamide, prednisolone, Anti-emetics:, ondansetron, granisetron, tropisetron, palonosetron, metoclopramide, prochlorperazine, lorazepam, aprepitant

R-CHOP and standard anti-emetics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Australasian Leukaemia and Lymphoma Group: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma; Vomiting; Nausea

Interventions

R-CHOP protocol; Rituximab; Doxorubicin; Vincristine; Cyclophosphamide; Prednisolone; Antiemetics; Ondansetron; Granisetron; Tropisetron; Palonosetron; Metoclopramide; Prochlorperazine; Lorazepam; Aprepitant

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Gastrointestinal Agents; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Heterocyclic Compounds, 3-Ring; Azabicyclo Compounds; Aza Compounds; Indazoles; Pyrazoles; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Quinuclidines; Isoquinolines; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Phenyl Ethers; Phenols; Phenothiazines; Sulfur Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Morpholines; Oxazines

Study Officials

• Andrew Grigg, Professor

  Director of Clinical Haematology, Austin Hospital, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: May 1, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 7, 2024

Record last verified: 2024-08