Nexium Study To Suppress Nausea During Chemotherapy

NCT00206440 | Terminated Phase 3 Results DMC

• 2 other identifiers: H-16348Nexium Study
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study will look at a drug called esomeprazole, the newest PPI, as a way to further reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin or epirubicin chemotherapy. Esomeprazole may help protect the gut lining from the stomach acid and thus lessen the nausea and vomiting. If patients have less stomach sickness, they may be able to enjoy their daily routines much more while they are getting chemotherapy.

Conditions

Nausea

Keywords

chemotherapy; nausea; vomiting; breast cancer

Outcome Measures

Primary Outcomes (1)

• Number of Times a Subject Felt Sick to Her Stomach and Number of Times a Subject Required Rescue Medication

  Proportion of patients who exhibit no more than one emetic episode and who do not require rescue medication for nausea from 2-7 days following chemotherapy. Thus, we will look at esomeprazole when used to decrease the incidence,severity and duration of nausea/vomiting/retching in breast cancer patients who are receiving anthracycline-based chemotherapy.

  2-7 days following chemotheraphy

Study Arms (2)

Esomeprazole

EXPERIMENTAL

Patients receiving chemotherapy (anthracycline-based) will be randomized to esomeprazole for Cycle 1 Days 1-5 and Cycle 2 Days 1-5

Drug: esomeprazole

Sugar pill

PLACEBO COMPARATOR

Subjects will be given placebo Cycle 1 Days 1-5 and Cycle 2 Days 1-5.

Other: Placebo

Interventions

esomeprazole DRUG

nexium

Also known as: nexium

Esomeprazole

Placebo OTHER

Placebo 1 pill daily Cycle 1 Days 1-5 and Cycle 2 Days 1-5

Also known as: Sugar Pill

Sugar pill

Eligibility Criteria

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

You may qualify if:

• be female, age 18 years or older
• sign an informed consent
• have Stage I, II, or III breast cancer
• be receiving at least four cycles of anthracycline-based chemotherapy which may include: doxorubicin/cyclophosphamide AC),5-fluorouracil/doxorubicin/cyclophosphamide (FAC), fluoruracil/epirubicin/cyclophosphamide (FEC) or dose dense chemotherapy regimen (AC every two weeks) as their agents for neoadjuvant or adjuvant chemotherapy
• patient must receive a serotonin receptor antagonist and a steroid for premedication
• have a negative serum pregnancy test within 7 days prior to starting study if pre-menopausal
• have adequate renal function, defined by a serum creatinine within 1.5 times the upper limit of normal
• have adequate liver function, defined by a total bilirubin, SGOT, alkaline phosphatase and albumin within 1.5 times the upper limits of normal
• have adequate bone marrow function, defined as a WBC \>4.0, platelet count \>100K, and HCT \>30
• have no prior or current malignancies for which chemotherapy was utilized
• have a performance status of at least 2 according to the Eastern Cooperative Oncology Group World Health Organization or a Karnofsky score of 50% or greater.

You may not qualify if:

• pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential
• severe or underlying chronic illness or disease
• renal insufficiency or liver abnormalities
• chronic use of steroids
• uncontrolled GERD
• current use of proton pump inhibitors
• history of Barrett's esophagus
• history of erosive gastritis
• intolerance to serotonin receptor antagonists
• current use of aprepitant or palonosetron as antiemetics
• concomitant use of H2-receptor antagonists (ranitidine, cimetidine, famotidine or nizatidine) or metaclopramide

Sponsors & Collaborators

• Baylor Breast Care Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Baylor Breast Center

Houston, Texas, 77030, United States

Location

Related Links

• Web site

MeSH Terms

Conditions

Nausea; Vomiting; Breast Neoplasms

Interventions

Esomeprazole; Sugars

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Results Point of Contact

• Title: Mothaffar Rimawi
• Organization: Baylor College of Medicine

rimawi@bcm.tmc.edu

713 798 1999

Study Officials

• Mothaffar Rimawi, MD

  Baylor Breast Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: August 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2012
• Last Updated: December 6, 2018
• Results First Posted: March 7, 2012

Record last verified: 2018-11

Locations

US (1)