NCT00716157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

3.8 years

First QC Date

July 14, 2008

Last Update Submit

December 3, 2014

Conditions

Cancer of the Head and NeckCancer of the LungCancer of the EsophagusGastro-esophageal Junction Cancer

Outcome Measures

Primary Outcomes (1)

  • Assess incidence and patterns of nausea and vomiting in patients undergoing concurrent chemotherapy and radiation

    week of treatment

Secondary Outcomes (2)

  • 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

Study Arms (1)

Observation

Adult patients receiving both radiation therapy and chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

University practice patients with aerodigestive malignancy

You may qualify if:

  • Concurrent radiation and chemotherapy treatment
  • Aerodigestive malignancy

You may not qualify if:

  • Other causes of vomiting (i.e.gastrointestinal obstruction...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsLung NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Rita Axelrod, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 16, 2008

Study Start

October 1, 2004

Primary Completion

August 1, 2008

Study Completion

September 1, 2011

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

US(1)