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.

Signe Harder

Status: Completed

Conditions: Advanced Cancer; Nausea; Emesis

Study type: Observational

Funder types: Other

Identifiers

NCT02980289

DANSAC-EPI

Details and patient eligibility

About

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

Enrollment: 821 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

821 participants in 1 patient group

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.