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.

Completed

• Conditions: Nausea; Advanced Cancer; Emesis

• Registration Number: NCT02980289
• Lead Sponsor: Signe Harder

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-02
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 821

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-item nausea-score from EORTC-QLQ-C15-Pal at baseline and 1 week	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Odense Universityhospital; 🇩🇰 Odense, Denmark