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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02980289

Enrollment

821

Registered

2016-12-02

Start date

2016-02-29

Completion date

2018-07-01

Last updated

2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer, Emesis, Nausea

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
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

Countries

Denmark

Outcome results