Treatment of Chemotherapy-induced Nausea and Vomiting

Uppsala University Hospital

Status and phase: Completed; Phase 2

Conditions: Vomiting; Nausea

Treatments: Drug: Placebo; Drug: Aprepitant (Emend)

Study type: Interventional

Funder types: Other

Identifiers

NCT01101529

EudraCT nr: 2009-010545-31

2009-010545-31 (EudraCT Number)

Details and patient eligibility

About

Delayed nausea is a common problem after high dose chemotherapy for bone marrow transplantation. This study wants to compare standard prophylactic anti-emetic therapy with the same treatment plus the drug aprepitant (Emend). The hypothesis is that addition of Emend will reduce nausea and vomiting.

Full description

A single centre randomized placebo-controlled phase II-study with a random assignment to experimental (EXP) or control (CTR) group. All patients with lymphoproliferative diseases ≥18 years of age, scheduled for myeloablative therapy before autologous stem cell transplantation at the Akademiska University Hospital in Uppsala, Sweden, will be included consecutively during one and a half year. A total of 90 patients (45 per treatment arm) will be accrued for this study. They will be invited by mail to participate in the study a couple of weeks before hospital entry. A random assignment to EXP or CTR will be performed by research nurses not participating in any other way in the study. Patients will be stratified for diagnosis which also means myeloablative therapy (lymphoma (BEAC) or myeloma (high-dose melphalan)), and the groups are expected to be similar in size. One box for each diagnosis (lymphoma and myeloma) will contain equal numbers of randomisation cards for the experimental and control groups, randomly mixed within each box. Cards will be picked consecutively by a research nurse not otherwise involved in the study. The EXP group will receive aprepitant (EMEND®) in combination with standard anti-emetic treatment and the CTR group will receive standard anti-emetic treatment. All treatment will be given in the hospital.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Able to communicate in Swedish
• Diagnosis of lymphoproliferative disease
• Scheduled for myeloablative therapy and autologous stem cell transplantation
• Written informed consent
• Able to swallow oral medications

Exclusion criteria

• Nausea at baseline (immediately before start of chemotherapy)
• Gastrointestinal obstruction or active peptic ulcer
• Current illness requiring chronic systemic steroids or requirement for chronic use of antiemetic agent(s)
• Hypersensitivity to any component of the study regimen
• Pregnancy or nursing
• Unrelenting hiccups
• Radiation therapy to pelvis or abdomen within 1 week before or after study day 1
• Psychiatric illness or multi-system organ failure
• Hepatic insufficiency with ASAT, ALAT three times over reference value
• Renal insufficiency with creatinin value three times over reference value.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Standard antiemetic therapy plus placebo

Placebo Comparator group

Description:

Standard anti-emetic prophylaxis consisting of 1/dexamethasone 6 mg daily during the chemotherapy days and 2/tropisetron (Navoban)5 mg daily during chemotherapy and 2 days after

Treatment:

Drug: Placebo

aprepitant (Emend)

Experimental group

Description:

Aprepitant given orally 125 mg the first day, then 80 mg daily during the chemotherapy course and 7 days after as an addition to standard antiemetic therapy as in the placebo arm.

Treatment:

Drug: Aprepitant (Emend)