Treatment of Chemotherapy-induced Nausea and Vomiting

NCT01101529 | Completed Phase 2

• 2 other identifiers: EudraCT nr: 2009-010545-312009-010545-31
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting

Keywords

Chemotherapy-induced nausea and vomiting CINV

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety and tolerability of the aprepitant regimen for CINV

  3 weeks

Study Arms (2)

Standard antiemetic therapy plus placebo

PLACEBO COMPARATOR

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

aprepitant (Emend)

EXPERIMENTAL

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)

Interventions

Aprepitant (Emend) 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

Also known as: Emend

aprepitant (Emend)

Placebo DRUG

Placebo will be administered instead of Emend

Standard antiemetic therapy plus placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University Hospital: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gunnar Birgegard, MD, PhD

  University Hospital, Uppsala, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 12, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

SE (1)