Treatment of Chemotherapy-induced Nausea and Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01101529
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : December 13, 2012
Information provided by (Responsible Party):
Gunnar Birgegard, Uppsala University Hospital

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.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Drug: Aprepitant (Emend) Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 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
Drug: Placebo
Placebo will be administered instead of Emend

Experimental: 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.
Drug: 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
Other Name: Emend

Primary Outcome Measures :
  1. Vomiting and nausea [ Time Frame: 7 days ]
    The proportion of patients with a complete response (no vomiting and/or only mild nausea and no use of rescue therapy) a/ during chemotherapy and b/ in the delayed phase (up to 7 days after end of chemotherapy).

Secondary Outcome Measures :
  1. Safety and tolerability of the aprepitant regimen for CINV [ Time Frame: 3 weeks ]
    Possible side effects will be recorded, and all AE:s reported during 3 weeks after the chemotherapy.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01101529

Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University Hospital
Principal Investigator: Gunnar Birgegard, MD, PhD University Hospital, Uppsala, Sweden

Responsible Party: Gunnar Birgegard, Prof, Uppsala University Hospital Identifier: NCT01101529     History of Changes
Other Study ID Numbers: EudraCT nr: 2009-010545-31
2009-010545-31 ( EudraCT Number )
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012

Keywords provided by Gunnar Birgegard, Uppsala University Hospital:
Chemotherapy-induced nausea and vomiting CINV

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action