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Clinical Trials/NCT00900068
NCT00900068
Terminated
Not Applicable

Substance P Follow-up to a Pilot Study of Aprepitant vs Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplantation

OHSU Knight Cancer Institute1 site in 1 country9 target enrollmentAugust 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
OHSU Knight Cancer Institute
Enrollment
9
Locations
1
Primary Endpoint
Average, median, and mode for substance P levels at different times
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about nausea and vomiting caused by cancer treatment.

PURPOSE: This laboratory study is looking at blood samples from patients with cancer who were treated on a clinical trial to control nausea and vomiting during donor stem cell transplant.

Detailed Description

OBJECTIVES: Primary * To compare the amount of substance P in serum samples from patients with cancer treated with busulfan/cyclophosphamide or cyclophosphamide/total body irradiation conditioning regimens prior to undergoing allogeneic hematopoietic stem cell transplantation. Secondary * To assess the changes in substance P over time to see if there is an optimal time shown by this physiologic correlate to discontinue substance P blockade after the chemotherapy regimen is completed in these patients. OUTLINE: Previously collected serum samples are analyzed by enzyme immunoassay for changes in substance P levels. Patients' medical records are reviewed for demographic information, past history, and course of treatment.

Registry
clinicaltrials.gov
Start Date
August 2008
End Date
October 2009
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joseph Bubalo

PharmD

OHSU Knight Cancer Institute

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Average, median, and mode for substance P levels at different times

Secondary Outcomes

  • Correlation of substance P levels with patient response (emesis or not)

Study Sites (1)

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