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.

NCT ID: NCT02980289

Last Updated: 2018-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

821 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-07-01

Brief Summary

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The study aims to investigate the prevalence and treatment of nausea and/or vomiting in patients with advanced cancer not receiving chemotherapy or irradiation.

Detailed Description

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Conditions

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Advanced Cancer Nausea Emesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Signe Harder

OTHER

Sponsor Role lead

Responsible Party

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Signe Harder

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Odense Universityhospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DANSAC-EPI

Identifier Type: -

Identifier Source: org_study_id

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