Prevalence of Cachexia in Patients Undergoing Chemotherapy

Cancer Clinical Trial

Official title:

Prevalence and Impact of Cachexia in Cancer Patients Undergoing Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939340
• Other study ID #: EA4/051/10
• Status: Completed
• Phase: N/A
• First received: September 6, 2013
• Last updated: September 11, 2013
• Start date: April 2010
• Est. completion date: May 2013

Study information

• Verified date: September 2013
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: May 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cachexia
• Cancer

Locations

Country	Name	City	State
Germany	Dept. of Gastroenterology, Infectiology and Rheumatology (including workspace nutrition medicine), Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional intake	Nutritional intake will be assessed by 24h-recall, which will be analysed with regard to macronutritients	1 day	No
Secondary	Cachexia	Cachexia will be evaluated using the patient-generated Subjective Global Assessment.	1 day	No
Secondary	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.	1 day	No
Secondary	Mortality	Mortality will be assesses via telephone or consultation of the local death register	6 months	No