Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence of Cachexia in Patients Undergoing Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01939340
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : September 12, 2013
Sponsor:
Information provided by (Responsible Party):
Nicole Stobaeus, Charite University, Berlin, Germany

Brief 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. Furthermore interactions between these parameters, tumor disease and chemotherapy, respectively.

Condition or disease
Cancer Cachexia

Layout table for study information
Study Type : Observational
Actual Enrollment : 285 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Impact of Cachexia in Cancer Patients Undergoing Chemotherapy
Study Start Date : April 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : May 2013



Primary Outcome Measures :
  1. Nutritional intake [ Time Frame: 1 day ]
    Nutritional intake will be assessed by 24h-recall, which will be analysed with regard to macronutritients


Secondary Outcome Measures :
  1. Cachexia [ Time Frame: 1 day ]
    Cachexia will be evaluated using the patient-generated Subjective Global Assessment.

  2. Quality of life and fatigue [ Time Frame: 1 day ]
    EORTC QLQ C-30 will be used to assess quality of life and additionally cancer-related fatigue will be evaluated using Brief Fatigue Inventory.

  3. Mortality [ Time Frame: 6 months ]
    Mortality will be assesses via telephone or consultation of the local death register



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be selected in primary care clinics.
Criteria

Inclusion Criteria:

  • Patients undergoing chemotherapy at least in the second cycle.
  • Patients who have signed a written Informed Consent.

Exclusion Criteria:

  • Patients with implanted pacemaker or defibrillator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939340


Locations
Layout table for location information
Germany
Dept. of Gastroenterology, Infectiology and Rheumatology (including workspace nutrition medicine), Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Layout table for investigator information
Principal Investigator: Jörg-Dieter Schulzke, Prof. Dr. Charite University, Berlin, Germany

Layout table for additonal information
Responsible Party: Nicole Stobaeus, MSc, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01939340     History of Changes
Other Study ID Numbers: EA4/051/10
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 12, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Layout table for MeSH terms
Cachexia
Wasting Syndrome
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders