Treatment of Chemotherapy-induced Nausea and Vomiting

Nausea Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101529
• Other study ID #: EudraCT nr: 2009-010545-31
• Secondary ID: 2009-010545-31
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2010
• Last updated: December 12, 2012
• Start date: May 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

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
• Placebo
Placebo will be administered instead of Emend

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vomiting and nausea	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).	7 days	No
Secondary	Safety and tolerability of the aprepitant regimen for CINV	Possible side effects will be recorded, and all AE:s reported during 3 weeks after the chemotherapy.	3 weeks	Yes