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.

Sponsors

Lead Sponsor: Signe Harder

Source Odense University Hospital
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.

Overall Status Completed
Start Date February 2016
Completion Date July 1, 2018
Primary Completion Date July 1, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
2-item nausea-score from EORTC-QLQ-C15-Pal at baseline and 1 week From baseline and at 1 week (5-9 days)
Secondary Outcome
Measure Time Frame
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)
Enrollment 821
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Odense Universityhospital
Location Countries

Denmark

Verification Date

August 2018

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Odense University Hospital

Investigator Full Name: Signe Harder

Investigator Title: Doctor

Has Expanded Access No
Condition Browse
Arm Group

Label: Patients

Description: 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.

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov