Clinical trial NCT01101529: Treatment of Chemotherapy-induced Nausea and Vomiting
Official title: A Randomized Controlled Study to Compare (EMEND®)to Standard Treatment as Prevention for Delayed Chemotherapy-induced Nausea and Vomiting (CINV) After Myeloablative Therapy for Patients Undergoing Autologous Stem Cell Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nausea
Vomiting
Keywords: Chemotherapy-induced nausea and vomiting CINV
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2010-04-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vomiting and nausea
timeFrame: 7 days
Secondary outcomes:
measure: Safety and tolerability of the aprepitant regimen for CINV
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: University Hospital, Uppsala, Sweden
name: Gunnar Birgegard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: