Treatment of Chemotherapy-induced Nausea and Vomiting

NCT ID: NCT01101529

Last Updated: 2012-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-12-31

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.

Conditions

Nausea; Vomiting

Keywords

Chemotherapy-induced nausea and vomiting CINV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Standard antiemetic therapy plus placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered instead of Emend

aprepitant (Emend)

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.

Group Type: EXPERIMENTAL

Aprepitant (Emend)

Intervention Type: DRUG

Aprepitant will be added to the standard anti-emetic therapy. Emend is given orally, 125 mg the first day, then 80 mg daily during the chemotherapy course and 7 days after

Interventions

Aprepitant (Emend)

Aprepitant will be added to the standard anti-emetic therapy. Emend is given orally, 125 mg the first day, then 80 mg daily during the chemotherapy course and 7 days after

Intervention Type: DRUG

Placebo

Placebo will be administered instead of Emend

Intervention Type: DRUG

Other Intervention Names

Emend

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gunnar Birgegard

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gunnar Birgegard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Uppsala, Sweden

Locations

Uppsala University Hospital

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

2009-010545-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EudraCT nr: 2009-010545-31

Identifier Type: -

Identifier Source: org_study_id