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Nutrition and Physical Exercise Study

This study is currently recruiting participants.
Verified December 2012 by Kantonsspital Winterthur KSW
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier:
NCT01540968
First received: February 23, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes

February 23, 2012
December 13, 2012
March 2012
March 2014   (final data collection date for primary outcome measure)
Quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01540968 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Nutrition and Physical Exercise Study
Influence of a Combined Intervention by Nutritional Support and Physical Exercise on Quality of Life in Cancer Out-patients Treated in Palliative Intention.

The purpose of this study is to investigate the effect of a combined treatment of nutritional therapy and physical exercise in palliative cancer out-patients. The investigators hypothesize that this combined intervention consisting of an increased energy- and protein intake and physical exercise level improves quality of life (QoL), functional and clinical status.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
  • Gastrointestinal Cancer
  • Lung Cancer
Behavioral: Nutrition & physical exercise
Patients will be randomly assigned to intensive individual nutritional counselling including oral nutritional supplements and a specifically designed exercise program combining strength and balance training.
  • Experimental: Nutrition & physical exercise
    Intervention: Behavioral: Nutrition & physical exercise
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
74
June 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic lung cancer or gastrointestinal cancer
  • WHO performance status 0, 1 or 2
  • Able to walk at least 100 meters independently without crutches or walking frame assessed by the treating physician on the basis of the patient's history and physical condition
  • Receiving palliative treatment

Exclusion Criteria:

  • Enteral and/or parenteral nutrition within 1 month previous to study participation
  • History of ileus within one month
  • Known brain metastases or symptomatic bone metastases
  • Psychiatric disorder precluding understanding of information on trial related topics and giving informed consent.
  • Any serious underlying medical condition which could impair the ability of the patient to participate in the trial
Both
18 Years and older
No
Contact: Peter E. Ballmer, Prof. Dr. 0041 52 266 23 02 peter.ballmer@ksw.ch
Contact: Alexandra - Uster, M.Sc. ETH 0041 52 266 23 27 alexandra.uster@ksw.ch
Switzerland
 
NCT01540968
KEK-ZH-Nr. 2011-0447, KFS-2833-08-2011
No
Kantonsspital Winterthur KSW
Kantonsspital Winterthur KSW
Not Provided
Study Chair: Peter E. Ballmer, Prof. Dr. Kantonsspital Winterthur KSW
Kantonsspital Winterthur KSW
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP