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NCT00716560 Clinical Trial

Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin

Metastatic Melanoma Clinical Trial

Official title:
Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00716560
Other study ID # 05C.202
Secondary ID 2004-10104020050
Status Terminated
Phase N/A
First received July 14, 2008
Last updated October 19, 2016
Start date May 2005
Est. completion date March 2009

Study information
Verified date October 2016
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to observe the incidence of nausea with systemic chemotherapy that includes consecutive days (more than one day)of cisplatin medication.

Description:

Questionnaires are completed on week of chemotherapy treatment referred to as Dartmouth regimen.

Recruitment information / eligibility
Status Terminated
Enrollment 8
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- confirmed diagnosis metastatic melanoma

- 18 years and older

- undergoing chemotherapy with Dartmouth regimen

- medically stable to receive chemotherapy per physical and clinical laboratory tests

Exclusion Criteria:

- No medical conditions that interfere with assessment of nausea and vomiting during chemotherapy

- No cognitive disorder that impairs symptom assessment

- No other investigational agent

- Inability to swallow medications for nausea and vomiting

- No gastric outlet obstruction

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

Locations
Country Name City State
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine incidence of nausea when receiving Dartmouth regimen chemotherapy for metastatic melanoma Week of treatment No
Secondary Assess the impact of systemic chemotherapy with Dartmouth regimen on quality of life of patients week of treatment No
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