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Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin

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ClinicalTrials.gov Identifier: NCT00716560
Recruitment Status : Terminated (Administratively terminated.)
First Posted : July 16, 2008
Last Update Posted : October 21, 2016
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Brief 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.

Condition or disease
Metastatic Melanoma Nausea

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

Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Only
Official Title: Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin
Study Start Date : May 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Group/Cohort
A
Metastatic melanoma treatment with Dartmouth regimen



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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Additional 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 Posted: July 16, 2008    Key Record Dates
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