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 Harder821 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

821

Conditions

Advanced Cancer Nausea Emesis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Odense Universityhospital

Odense, Denmark

Outcomes

Primary Outcomes

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.

Time frame: From baseline and at 1 week (5-9 days)

Secondary Outcomes

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

Time frame: 1 week (5-9 days)

Nausea at screening from EORTC-QLQ-C15-Pal at baseline

Prevalence of nausea at time of screening, related to age, cancer-diagnosis and gender

Time frame: At baseline

Emesis at screening from EORTC-QLQ-C15-Pal at baseline

Prevalence of emesis at time of screening, related to age, cancer-diagnosis and gender

Time frame: At baseline

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

Time frame: From baseline and at 1 week (5-9 days)

Data from ClinicalTrials.gov

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