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.

An observational study of Advanced Cancer and Nausea, run by Signe Harder at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Cancer, Nausea, Emesis
How many people: 821 participants
Where: 1 siteDenmark
Study dates: Feb 2016to 1 Jul 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with advanced cancer, who have not received chemo- or radiotherapy in the last 4 weeks prior to screening, will be screened for nausea and/or vomiting following evaluation of the primary inclusion-/exclusion criteria. The patients can be located either in the hospital departments, at home or in a hospice.

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Odense Universityhospital
Odense, 5000

Other trials in Denmark

About this study

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

Conditions: Advanced Cancer, Nausea, Emesis
Medical subject headings: Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02980289
Study group	Role	What they receive
Patients		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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From baseline and at 1 week (5-9 days)

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 20161 Jul 2018

First posted2 Dec 2016 (estimated)
Study startFeb 2016
Primary completion1 Jul 2018
Study completion1 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 821 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02980289
Sponsor's protocol ID: DANSAC-EPI
Status last verified: Aug 2018
First submitted: 7 Mar 2016
Last updated: 23 Aug 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Advanced Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT02980289
Acronym / sponsor ID: DANSAC-EPI
Conditions: Advanced Cancer, Nausea, Emesis
Study type: Observational
Recruitment status: Completed
Enrolment: 821 participants (actual)
Lead sponsor: Signe HarderUniversity, hospital or other
Study start: Feb 2016
Primary completion: 1 Jul 2018 (actual)
Study completion: 1 Jul 2018 (actual)
First posted: 2 Dec 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients	–	–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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with advanced cancer, who have not received chemo- or radiotherapy in the last 4 weeks prior to screening, will be screened for nausea and/or vomiting following evaluation of the primary inclusion-/exclusion criteria. The patients can be located either in the hospital departments, at home or in a hospice.

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

4 secondary outcomes

Nausea CAT-score from EORTC-QLQ-C15-Pal at baseline and after 1 week
Time frame: 1 week (5-9 days)
Nausea at screening from EORTC-QLQ-C15-Pal at baseline
Time frame: At baseline
Emesis at screening from EORTC-QLQ-C15-Pal at baseline
Time frame: At baseline
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
Individual participant dataSharing planned: No

Related trials for Advanced Cancer

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Cancer and Nausea, run by Signe Harder at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02980289.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.