Conditions: Nausea Vomiting
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 111
Healthy volunteers: no

Brief summary:
This study will assess the efficacy of a single dose of intravenous (IV) fosaprepitant (MK-0517, EMEND® IV) as salvage therapy when added to a 5-hydroxytryptamine receptor 3 antagonist (5-HT3 RA) and dexamethasone for the prevention of chemotherapy-induced vomiting (CIV) in participants who experienced CIV in the first cycle of moderately emetic chemotherapy (MEC). The primary hypothesis is that there will be no vomiting and no retching in at least 20% of participants during the second cycle of MEC in participants who previously experienced vomiting during the first cycle of MEC.

Detailed description:

Arms:
arm 1: Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy

Interventions: intervention 1: Fosaprepitant dimeglumine intervention 2: 5-HT3 RA intervention 3: Dexamethasone intervention 4: Rescue medication
Intervention descriptions: intervention 1: Fosaprepitant 150 mg, IV on Day 1 of chemotherapy in Cycle 2 intervention 2: 5-HT3 RA will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy. intervention 3: Dexamethasone will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy. intervention 4: Rescue medication is defined as any medication used to relieve the symptoms of established nausea or vomiting. Multiple medications are permitted by the protocol and may be taken by the participant, including 5-HT3 antagonists, phenothiazines and benzodiazepines.

Protocol document: