NCT01939340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
Last Updated

September 12, 2013

Status Verified

September 1, 2013

Enrollment Period

2.4 years

First QC Date

September 6, 2013

Last Update Submit

September 11, 2013

Conditions

CancerCachexia

Outcome Measures

Primary Outcomes (1)

  • Nutritional intake

    Nutritional intake will be assessed by 24h-recall, which will be analysed with regard to macronutritients

    1 day

Secondary Outcomes (3)

  • Cachexia

    1 day

  • Quality of life and fatigue

    1 day

  • Mortality

    6 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be selected in primary care clinics.

You may qualify if:

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

You may not qualify if:

  • Patients with implanted pacemaker or defibrillator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Gastroenterology, Infectiology and Rheumatology (including workspace nutrition medicine), Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

NeoplasmsCachexia

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Jörg-Dieter Schulzke, Prof. Dr.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

September 6, 2013

First Posted

September 11, 2013

Study Start

April 1, 2010

Primary Completion

September 1, 2012

Study Completion

May 1, 2013

Last Updated

September 12, 2013

Record last verified: 2013-09

Locations

DE(1)