Treatment of Chemotherapy-induced Nausea and Vomiting

• Sponsor: Uppsala University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01101529
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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 1, 2010
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

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 Names: Emend

Outcome Measures

Primary Outcome Measures

1. Vomiting and nausea [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 [3 weeks]

   Possible side effects will be recorded, and all AE:s reported during 3 weeks after the chemotherapy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uppsala University Hospital	Uppsala		Sweden	75185

Sponsors and Collaborators

• Uppsala University Hospital

Investigators

• Principal Investigator: Gunnar Birgegard, MD, PhD, University Hospital, Uppsala, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gunnar Birgegard, Prof, Uppsala University Hospital
• ClinicalTrials.gov Identifier: NCT01101529
• Other Study ID Numbers: EudraCT nr: 2009-010545-31; 2009-010545-31
• First Posted: Apr 12, 2010
• Last Update Posted: Dec 13, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by Gunnar Birgegard, Prof, Uppsala University Hospital: Chemotherapy-induced nausea and vomiting CINV
• Additional relevant MeSH terms: Nausea; Vomiting; Aprepitant

Study Results

No Results Posted as of Dec 13, 2012