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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02980289
Other study ID # DANSAC-EPI
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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