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Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin

This study has been terminated.
(Administratively terminated.)
Sponsor:
Collaborator:
Merck
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00716560
First received: July 14, 2008
Last updated: August 18, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition
Metastatic Melanoma
Nausea

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin

Resource links provided by NLM:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Determine incidence of nausea when receiving Dartmouth regimen chemotherapy for metastatic melanoma [ Time Frame: Week of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the impact of systemic chemotherapy with Dartmouth regimen on quality of life of patients [ Time Frame: week of treatment ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: May 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Metastatic melanoma treatment with Dartmouth regimen

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

University practice patients with metastatic melanoma

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716560

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Merck
Investigators
Principal Investigator: Takami Sato, M.D.,Ph.D. Thomas Jefferson University
  More Information

Additional Information:
Kimmel Cancer Center at Thomas Jefferson University  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Takami Sato, MD, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00716560     History of Changes
Other Study ID Numbers: 05C.202, 2004-101, 0402005015
Study First Received: July 14, 2008
Last Updated: August 18, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Melanoma
Nausea
Vomiting
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Signs and Symptoms, Digestive
Signs and Symptoms
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013