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.

Advanced Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980289
• Other study ID #: DANSAC-EPI
• Status: Completed
• Start date: February 2016
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2018
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 821
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Emesis
• Nausea
• Neoplasms

Locations

Country	Name	City	State
Denmark	Odense Universityhospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Signe Harder

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nausea CAT-score from EORTC-QLQ-C15-Pal at baseline and after 1 week	Change in nausea CAT-score from baseline to 24 hours and 7 days	1 week (5-9 days)
Secondary	Nausea at screening from EORTC-QLQ-C15-Pal at baseline	Prevalence of nausea at time of screening, related to age, cancer-diagnosis and gender	At baseline
Secondary	Emesis at screening from EORTC-QLQ-C15-Pal at baseline	Prevalence of emesis at time of screening, related to age, cancer-diagnosis and gender	At baseline
Secondary	Change in other parameters from EORTC-QLQ-C15-Pal at baseline and after 1 week	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)