DAnish Nausea Study In Advanced Cancer-Epidemiology: A Danish Multicenter Trial to Investigate the Prevalence and Treatment of Nausea and/or Vomiting in Patients With Advanced Cancer.

August 22, 2018 updated by: Signe Harder
The study aims to investigate the prevalence and treatment of nausea and/or vomiting in patients with advanced cancer not receiving chemotherapy or irradiation.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

821

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense Universityhospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with advanced cancer, who have not received chemo- or radiotherapy in the last 4 weeks prior to screening, will be screened for nausea and/or vomiting following evaluation of the primary inclusion-/exclusion criteria. The patients can be located either in the hospital departments, at home or in a hospice.

Description

Inclusion Criteria:

  1. Advanced cancer
  2. Age ≥ 18 years
  3. Ability to read and understand the forms required for the study
  4. Life-expectancy more than 2 weeks.
  5. Nausea score ≥ 'a little' on the extended EORTC QLQ-C15-PAL (item 9)

Exclusion Criteria:

  1. Surgery to the brain or abdomen within the last 2 weeks or exposure to general anesthesia within the last 4 days.
  2. Chemotherapy or radiation therapy within the last 4 weeks
  3. Symptoms of increased intracranial pressure or cerebral metastasis. If this is suspected, a normal MRI scan of the cerebrum is needed before inclusion
  4. Radiologically confirmed ileus, or strong clinical suspicion evaluated by the study Investigator
  5. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients
Patients over 18 years old with advanced cancer defined as metastatic disease, no curable treatment options. The patients may not have received chemotherapy or irradiation within 4 weeks, no operations within 2 weeks and no general anesthesia within 4 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-item nausea-score from EORTC-QLQ-C15-Pal at baseline and 1 week
Time Frame: From baseline and at 1 week (5-9 days)
The primary objective is to observe the effect of standard anti-emetics on change in two-item nausea-score from baseline to 24 hours.
From baseline and at 1 week (5-9 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea CAT-score from EORTC-QLQ-C15-Pal at baseline and after 1 week
Time Frame: 1 week (5-9 days)
Change in nausea CAT-score from baseline to 24 hours and 7 days
1 week (5-9 days)
Nausea at screening from EORTC-QLQ-C15-Pal at baseline
Time Frame: At baseline
Prevalence of nausea at time of screening, related to age, cancer-diagnosis and gender
At baseline
Emesis at screening from EORTC-QLQ-C15-Pal at baseline
Time Frame: At baseline
Prevalence of emesis at time of screening, related to age, cancer-diagnosis and gender
At baseline
Change in other parameters from EORTC-QLQ-C15-Pal at baseline and after 1 week
Time Frame: From baseline and at 1 week (5-9 days)
Change in other parameters potentially indicative of efficacy: appetite, fatigue, pain, emotional function and overall quality of life
From baseline and at 1 week (5-9 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Signe Harder

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DANSAC-EPI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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