Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin
This study has been terminated.
(Administratively terminated.)
Sponsor:
Thomas Jefferson University
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 14, 2008 | ||||
| Last Updated Date | August 18, 2010 | ||||
| Start Date ICMJE | May 2005 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Determine incidence of nausea when receiving Dartmouth regimen chemotherapy for metastatic melanoma [ Time Frame: Week of treatment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00716560 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin | ||||
| Official Title ICMJE | Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin | ||||
| 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. |
||||
| Detailed Description | Questionnaires are completed on week of chemotherapy treatment referred to as Dartmouth regimen. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | University practice patients with metastatic melanoma |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | A
Metastatic melanoma treatment with Dartmouth regimen |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 8 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00716560 | ||||
| Other Study ID Numbers ICMJE | 05C.202, 2004-101, 0402005015 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Takami Sato, MD, Thomas Jefferson University | ||||
| Study Sponsor ICMJE | Thomas Jefferson University | ||||
| Collaborators ICMJE | Merck | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Thomas Jefferson University | ||||
| Verification Date | August 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||