MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed chemotherapy-induced nausea and vomiting (CINV) induced by non- anthracyclines plus cyclophosphamide (AC) based moderately emetogenic chemotherapy (MEC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Collaborators: Gemini Ziekenhuis; Medisch Centrum Alkmaar; Noordwest Ziekenhuisgroep; Rijnstate; Tergooiziekenhuizen locatie Hilversum; Waterland Ziekenhuis; Zaans Medisch Centrum; Ziekenhuis Amstelland
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Emetics; Metoclopramide; Palonosetron

Criteria

Inclusion Criteria:

• Patient has been diagnosed with histologically or cytologically confirmed solid cancer

• Starting with first cycle of chemotherapy of moderate emetogenic risk, which does not include a combination of anthracycline plus cyclophosphamide

• Age ≥ 18

• WHO ≤ 1

• Patient is able to understand and speak Dutch

Exclusion Criteria:

• Patient with nausea and/or vomiting in 48 hours before start of chemotherapy treatment

• Patient submitted to concomitant radiotherapy or submitted to radiotherapy 15 days before start of chemotherapy or planned to receive radiotherapy during 8 days after administration of chemotherapy

• Patient with concomitant severe comorbidy, such as: o Intestinal obstruction o Active peptic ulcer o Hypercalcemia o Uncontrolled diabetes mellitus o Pheochromocytoma o Tardive dyskinesia o Epilepsia o Active infective diseases o Brain - or leptomeningeal metastases o Psychiatrical disorders o Parkinsonism

• Current use of corticosteroids (similar to prednisone ≥ 10 milligrams per day)

• Current alcohol abuse

• Pregnancy