We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin

This study has been terminated.
(Administratively terminated.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716560
First Posted: July 16, 2008
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
  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:


Further study details as provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):

Primary Outcome Measures:
  • Determine incidence of nausea when receiving Dartmouth regimen chemotherapy for metastatic melanoma [ Time Frame: Week of treatment ]

Secondary Outcome Measures:
  • Assess the impact of systemic chemotherapy with Dartmouth regimen on quality of life of patients [ Time Frame: week of treatment ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716560


Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Takami Sato, M.D.,Ph.D. Thomas Jefferson University
  More Information

Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00716560     History of Changes
Other Study ID Numbers: 05C.202
2004-101 ( Other Identifier: CCRRC )
0402005015 ( Other Grant/Funding Number: Merck & Co, Inc. )
First Submitted: July 14, 2008
First Posted: July 16, 2008
Last Update Posted: October 21, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Cisplatin
Antineoplastic Agents