Cancer of the Head and NeckNCT00716157
Incidence and Patterns of Nausea/Vomiting With Combined Chemotherapy and Radiation
An observational study of Cancer of the Head and Neck and Cancer of the Lung, run by Thomas Jefferson University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Head and Neck, Cancer of the Lung, Cancer of the Esophagus
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University practice patients with aerodigestive malignancy
Who may be able to join
- Concurrent radiation and chemotherapy treatment
- Aerodigestive malignancy
Who cannot join
- Other causes of vomiting (i.e.gastrointestinal obstruction...)
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Prospective Study to Evaluate the Incidence and Patterns of Nausea and Vomiting in Patients Receiving Combined Chemotherapy and Radiation
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.
Read the detailed description
Questionnaires will be answered daily on a weekly basis during period of radiation and chemotherapy.
- Conditions
- Cancer of the Head and Neck, Cancer of the Lung, Cancer of the Esophagus, Gastro-esophageal Junction Cancer
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Adult patients receiving both radiation therapy and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess incidence and patterns of nausea and vomiting in patients undergoing concurrent chemotherapy and radiation
Measured: week of treatment
Secondary outcomes (2)
Assess the impact of nausea and vomiting on the patients' daily functioning
Measured: week of treatment
Study the incidence of mucositis and esophagitis
Measured: week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startOct 2004
- Primary completionAug 2008
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Rita Axelrod, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716157
- Sponsor's protocol ID
- 04C.466
- Other IDs
- 2004-16, 1002004024
- Status last verified
- Dec 2014
- First submitted
- 14 Jul 2008
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Incidence and Patterns of Nausea and Vomiting in Patients Receiving Combined Chemotherapy and Radiation
- ClinicalTrials.gov ID
- NCT00716157
- Acronym / sponsor ID
- 04C.466
- Conditions
- Cancer of the Head and Neck, Cancer of the Lung, Cancer of the Esophagus, Gastro-esophageal Junction Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Adult patients receiving both radiation therapy and chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University practice patients with aerodigestive malignancy
Key inclusion criteria (2 listed)
- Concurrent radiation and chemotherapy treatment
- Aerodigestive malignancy
Key exclusion criteria (1 listed)
- Other causes of vomiting (i.e.gastrointestinal obstruction...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess incidence and patterns of nausea and vomiting in patients undergoing concurrent chemotherapy and radiation
Time frame: week of treatment
2 secondary outcomes
Assess the impact of nausea and vomiting on the patients' daily functioning
Time frame: week of treatment
Study the incidence of mucositis and esophagitis
Time frame: week of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Axelrod, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of the Head and Neck and Cancer of the Lung, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess incidence and patterns of nausea and vomiting in patients undergoing concurrent chemotherapy and radiation (time frame: week of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.