CancerNCT01939340
Prevalence of Cachexia in Patients Undergoing Chemotherapy
An observational study of Cancer and Cachexia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Cachexia and low nutritional intake are a common phenomena in cancer patients undergoing chemotherapy. The purpose of this study is to assess prevalence of cachexia and low nutritional intake and the impact on quality of life, fatigue and mortality in patients undergoing chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- How many people
- 285 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to May 2013
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected in primary care clinics.
Who may be able to join
- Patients undergoing chemotherapy at least in the second cycle.
- Patients who have signed a written Informed Consent.
Who cannot join
- Patients with implanted pacemaker or defibrillator.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Gastroenterology, Infectiology and Rheumatology (including workspace nutrition medicine), Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
Official title: Prevalence and Impact of Cachexia in Cancer Patients Undergoing Chemotherapy
Cachexia and low nutritional intake are a common phenomena in cancer patients undergoing chemotherapy. The purpose of this study is to assess prevalence of cachexia and low nutritional intake and the impact on quality of life, fatigue and mortality in patients undergoing chemotherapy. Furthermore interactions between these parameters, tumor disease and chemotherapy, respectively.
- Medical subject headings
- Neoplasms, Cachexia
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional intake
Nutritional intake will be assessed by 24h-recall, which will be analysed with regard to macronutritients
Measured: 1 day
Secondary outcomes (3)
Cachexia
Cachexia will be evaluated using the patient-generated Subjective Global Assessment.
Measured: 1 day
Quality of life and fatigue
EORTC QLQ C-30 will be used to assess quality of life and additionally cancer-related fatigue will be evaluated using Brief Fatigue Inventory.
Measured: 1 day
Mortality
Mortality will be assesses via telephone or consultation of the local death register
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startApr 2010
- Primary completionSep 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Stobaeus, Charite University, Berlin, Germany
- Investigators
- Jörg-Dieter Schulzke, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939340
- Sponsor's protocol ID
- EA4/051/10
- Status last verified
- Sep 2013
- First submitted
- 6 Sep 2013
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Impact of Cachexia in Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT01939340
- Acronym / sponsor ID
- EA4/051/10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Sep 2013 (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.
Cachexia and low nutritional intake are a common phenomena in cancer patients undergoing chemotherapy. The purpose of this study is to assess prevalence of cachexia and low nutritional intake and the impact on quality of life, fatigue and mortality in patients undergoing chemotherapy. Furthermore interactions between these parameters, tumor disease and chemotherapy, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected in primary care clinics.
Key inclusion criteria (2 listed)
- Patients undergoing chemotherapy at least in the second cycle.
- Patients who have signed a written Informed Consent.
Key exclusion criteria (1 listed)
- Patients with implanted pacemaker or defibrillator.
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
Nutritional intake
Time frame: 1 day
Nutritional intake will be assessed by 24h-recall, which will be analysed with regard to macronutritients
3 secondary outcomes
Cachexia
Time frame: 1 day
Quality of life and fatigue
Time frame: 1 day
Mortality
Time frame: 6 months
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 12 Sep 2013.
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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.
Jörg-Dieter Schulzke, Prof. Dr. principal investigator
Charite University, Berlin, Germany
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 Cancer and Cachexia, run by Charite University, Berlin, Germany at 1 site in Germany.
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 2 inclusion and 1 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 12 Sep 2013. 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 Germany. 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?
Nutritional intake (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2013.