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Completed

NCT Number: NCT02980289

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.

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

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Key information

Conditions

Advanced Cancer Emesis Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense Universityhospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Advanced cancer
  • Age ≥ 18 years
  • Ability to read and understand the forms required for the study
  • Life-expectancy more than 2 weeks.
  • Nausea score ≥ 'a little' on the extended EORTC QLQ-C15-PAL (item 9)

Exclusion criteria

  • Surgery to the brain or abdomen within the last 2 weeks or exposure to general anesthesia within the last 4 days.
  • Chemotherapy or radiation therapy within the last 4 weeks
  • Symptoms of increased intracranial pressure or cerebral metastasis. If this is suspected, a normal MRI scan of the cerebrum is needed before inclusion
  • Radiologically confirmed ileus, or strong clinical suspicion evaluated by the study Investigator
  • Pregnancy

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Nausea CAT-score from EORTC-QLQ-C15-Pal at baseline and after 1 week

    Time frame: 1 week (5-9 days)

    Change in nausea CAT-score from baseline to 24 hours and 7 days

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

    Time frame: At baseline

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

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

    Time frame: At baseline

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

  4. Change in other parameters from EORTC-QLQ-C15-Pal at baseline and after 1 week

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Signe Harder

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2016
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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