Incidence and Patterns of Nausea/Vomiting With Combined C... | NCT00716157

Studies
Incidence and Patterns of Nausea/Vomiting With Combined Chemotherapy and Radiation

NCT00716157

Sponsor

Thomas Jefferson University

Status

Completed

Last Update Posted

Dec 5, 2014Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Cancer of the Head and Neck
Cancer of the Lung
Cancer of the Esophagus
Gastro-esophageal Junction Cancer

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	Link
2004-16	Other Identifier	CCRRC
1002004024	Other Grant/Funding Number	Merck

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Aug 2008Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jul 14, 2008

First Submission Date that Met QC Criteria

Jul 15, 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

Dec 3, 2014

Last Update Posted Date

Dec 5, 2014Estimated

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

Questionnaire study to observe the incidence and pattern or nausea and vomiting in patients receiving combined chemotherapy and radiation. 83% of patients experience radiation therapy-induced vomiting; significant nausea and vomiting could develop with concurrent chemotherapy despite standard anti-nauseous medication prophylaxis.

Detailed Description

Questionnaires will be answered daily on a weekly basis during period of radiation and chemotherapy.

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observation		Adult patients receiving both radiation therapy and chemotherapy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess incidence and patterns of nausea and vomiting in patients undergoing concurrent chemotherapy and radiation		week of treatment

Secondary Outcomes

Measure	Description	Time Frame
Assess the impact of nausea and vomiting on the patients' daily functioning		week of treatment
Study the incidence of mucositis and esophagitis		week of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Concurrent radiation and chemotherapy treatment
Aerodigestive malignancy

Exclusion Criteria:

Other causes of vomiting (i.e.gastrointestinal 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 aerodigestive malignancy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rita Axelrod, MD	Thomas Jefferson University	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms
D008175	Lung Neoplasms
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided