Nausea and Vomiting In Patients Receiving Consecutive Day... | NCT00716560

Studies
Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin

NCT00716560

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Status

Terminated

Last Update Posted

May 6, 2025Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Metastatic Melanoma
Nausea

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
2004-101	Other Identifier	CCRRC
0402005015	Other Grant/Funding Number	Merck & Co, Inc.
JT 1069	Other Identifier	JeffTrial Number

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Administratively terminated.

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Jul 14, 2008

First Submission Date that Met QC Criteria

Jul 14, 2008

First Posted Date

Jul 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2025

Last Update Posted Date

May 6, 2025Actual

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Label	Type	Description	Intervention Names
A		Metastatic melanoma treatment with Dartmouth regimen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine incidence of nausea when receiving Dartmouth regimen chemotherapy for metastatic melanoma		Week of treatment

Secondary Outcomes

Measure	Description	Time Frame
Assess the impact of systemic chemotherapy with Dartmouth regimen on quality of life of patients		week of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

University practice patients with metastatic melanoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Takami Sato, M.D.,Ph.D.	Thomas Jefferson University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Jefferson University Hospital		Philadelphia	Pennsylvania	19107	United States

Label	URL
Kimmel Cancer Center at Thomas Jefferson University	View source

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma
D009325	Nausea

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided