Blood Samples From Patients on a Clinical Trial to CINV During HSCT

Terminated

• Conditions: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Breast Cancer; Gestational Trophoblastic Tumor; Nausea and Vomiting; Ovarian Cancer; Chronic Myeloproliferative Disorders; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm

• Registration Number: NCT00900068
• Lead Sponsor: OHSU Knight Cancer Institute

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2009-08
• Study Completion: 2009-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-07
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation of substance P levels with patient response (emesis or not)

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States