Delayed Nausea and Vomiting in Patients With Colorectal Cancer Receiving Oxaliplatin

An observational study of Colorectal Cancer and Nausea, run by Beth Israel Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

RATIONALE: Learning how often patients experience nausea and vomiting after receiving anti-vomiting medicine and chemotherapy for colorectal cancer may help doctors plan better treatment and improve patients' quality of life. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer, Nausea, Vomiting
How many people: 64 participants
Where: 1 siteUnited States
Study dates: Jun 2005to Dec 2008
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Patients receiveing chemotherapy including oxaliplatin at the ambulatory care center

DISEASE CHARACTERISTICS:

Diagnosis of colorectal cancer
Currently receiving OR scheduled to receive the first course of either of the following chemotherapy regimens:
mFOLFOX6
FOLFOX7
No clinical or imaging evidence of brain metastasis

PATIENT CHARACTERISTICS:

Able to maintain a diary and complete a standardized quality of life questionnaire in English

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 90 days since prior aprepitant

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Medical Center - Philipps Ambulatory Care Center
New York, New York, 10003

Other trials in United States

About this study

Official title: Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer

PURPOSE: This clinical trial is studying delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-vomiting medicine during the first course of chemotherapy.

Read the detailed description

OBJECTIVES:

To assess the prevalence of delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-emetic medications during the first course of an oxaliplatin-based chemotherapy regimen (mFOLFOX6 or FOLFOX7).

OUTLINE: This is a multicenter study.

Patients undergo collection of demographic, diagnostic, and treatment data at baseline. Patients complete the Functional Living Index-Emesis (FLIE) questionnaire at baseline prior to first chemotherapy infusion and at 5-7 days. Patients also fill out daily patient diaries about symptoms of nausea and vomiting, and use of medications to prevent these symptoms over days 1-5.

Conditions: Colorectal Cancer, Nausea, Vomiting
Keywords: nausea and vomiting, colon cancer, rectal cancer
Medical subject headings: Colorectal Neoplasms, Nausea, Vomiting, Colonic Neoplasms, Rectal Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy
Measured: Week 1 of FOLFOX chemotherapy
Impact of Nausea and Vomiting on the Patient's Quality of Life as Measured by the Functional Living Index - Emesis Scale at 5-7 Days
Scale describing impact of nausea and vomiting on quality of life on a seven-point Likert Scale with higher score indicating worse quality of life.
Measured: Week 1
Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy
Number of participants with factors associated with increased frequency of nausea in the first cycle of chemotherapy, including history of motion sickness, history of pregnancy-related morning sickness, history of prior chemotherapy, and history of nausea associated with prior chemotherapy
Measured: week 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2005Dec 2008

First posted7 Aug 2008 (estimated)
Study startJun 2005
Primary completionNov 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
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: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00729677
Sponsor's protocol ID: 237-04
Other IDs: BIMCP-NV-SURVEY, BIMCP-IRB-37-04, MERCK-BIMCP-NV-SURVEY
Status last verified: Oct 2015
First submitted: 6 Aug 2008
Last updated: 26 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevalence of Delayed Nausea and Vomiting in Patients Being Treated With Oxaliplatin-based Regimens (mFOLFOX6 or FOLFOX7) for Colorectal Cancer
ClinicalTrials.gov ID: NCT00729677
Acronym / sponsor ID: 237-04
Conditions: Colorectal Cancer, Nausea, Vomiting
Keywords: nausea and vomiting, colon cancer, rectal cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Beth Israel Medical CenterUniversity, hospital or other
Study start: Jun 2005
Primary completion: Nov 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 7 Aug 2008 (estimated)
Results: Posted 18 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

PURPOSE: This clinical trial is studying delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-vomiting medicine during the first course of chemotherapy.

Detailed description

OBJECTIVES:

To assess the prevalence of delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-emetic medications during the first course of an oxaliplatin-based chemotherapy regimen (mFOLFOX6 or FOLFOX7).

OUTLINE: This is a multicenter study.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients receiveing chemotherapy including oxaliplatin at the ambulatory care center

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

Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy
Time frame: Week 1 of FOLFOX chemotherapy
Impact of Nausea and Vomiting on the Patient's Quality of Life as Measured by the Functional Living Index - Emesis Scale at 5-7 Days
Time frame: Week 1
Scale describing impact of nausea and vomiting on quality of life on a seven-point Likert Scale with higher score indicating worse quality of life.
Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy
Time frame: week 1
Number of participants with factors associated with increased frequency of nausea in the first cycle of chemotherapy, including history of motion sickness, history of pregnancy-related morning sickness, history of prior chemotherapy, and history of nausea associated with prior chemotherapy

Results and safety

Results posted to the registry on 18 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Colorectal Cancer Starting Chemotherapy	64	64

Primary outcome: Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy

Time frame: Week 1 of FOLFOX chemotherapy. Number. Unit: percentage of participants

Measure	Females n = 28	Males n = 35	Transgender n = 1
Value	64	34	100

Females vs Males vs Transgender: p = .05, ANOVA

Primary outcome: Impact of Nausea and Vomiting on the Patient's Quality of Life as Measured by the Functional Living Index - Emesis Scale at 5-7 Days

Time frame: Week 1

Population analysed: this data was not collected

Primary outcome: Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy

Time frame: week 1. Number. Unit: participants

Measure	Participants With History of Nausea n = 23	Participants With No History of Nausea n = 41
nausea	14	17
No nausea	9	24

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Colorectal Cancer Starting Chemotherapy	0 of 64 (0%)	0 of 64 (0%)	Not reported

Limitations and caveats (from the sponsor): This was a convenience sample of patients seen at 2 medical centers. Subjects were restricted to those who could complete Quality of Life forms in Spanish or English.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Colorectal Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

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.

Stewart Barry Fleishman, MD principal investigator

Beth Israel Medical Center

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 Colorectal Cancer and Nausea, run by Beth Israel Medical Center 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?

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 26 Oct 2015. 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?

Yes. Results are posted in the registry (first posted 18 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy (time frame: Week 1 of FOLFOX chemotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00729677.

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 26 Oct 2015.