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.
1 other identifier
observational
821
1 country
1
Brief Summary
The study aims to investigate the prevalence and treatment of nausea and/or vomiting in patients with advanced cancer not receiving chemotherapy or irradiation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 7, 2016
CompletedFirst Posted
Study publicly available on registry
December 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedAugust 23, 2018
August 1, 2018
2.4 years
March 7, 2016
August 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
2-item nausea-score from EORTC-QLQ-C15-Pal at baseline and 1 week
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 Outcomes (4)
Nausea CAT-score from EORTC-QLQ-C15-Pal at baseline and after 1 week
1 week (5-9 days)
Nausea at screening from EORTC-QLQ-C15-Pal at baseline
At baseline
Emesis at screening from EORTC-QLQ-C15-Pal at baseline
At baseline
Change in other parameters from EORTC-QLQ-C15-Pal at baseline and after 1 week
From baseline and at 1 week (5-9 days)
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- Advanced cancer
- Age ≥ 18 years
- Ability to read and understand the forms required for the study
- Life-expectancy more than 2 weeks.
- Nausea score ≥ 'a little' on the extended EORTC QLQ-C15-PAL (item 9)
You may not qualify if:
- Surgery to the brain or abdomen within the last 2 weeks or exposure to general anesthesia within the last 4 days.
- Chemotherapy or radiation therapy within the last 4 weeks
- Radiologically confirmed ileus, or strong clinical suspicion evaluated by the study Investigator
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Signe Harderlead
Study Sites (1)
Odense Universityhospital
Odense, 5000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
March 7, 2016
First Posted
December 2, 2016
Study Start
February 1, 2016
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
August 23, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share