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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
  Purpose

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.


Condition Intervention
Gastrointestinal Cancer
Lung Cancer
 Behavioral: Nutrition & physical exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Influence of a Combined Intervention by Nutritional Support and Physical Exercise on Quality of Life in Cancer Out-patients Treated in Palliative Intention.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kantonsspital Winterthur KSW:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 74
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutrition & physical exercise 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.
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540968

Contacts
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

Locations
Switzerland
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, 8401
Contact: Peter E. Ballmer, Prof. Dr.         peter.ballmer@ksw.ch    
Contact: Alexandra Uster, M.Sc. ETH         alexandra.uster@ksw.ch    
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Investigators
Study Chair: Peter E. Ballmer, Prof. Dr. Kantonsspital Winterthur KSW
  More Information

No publications provided

Responsible Party: Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT01540968     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2011-0447, KFS-2833-08-2011
Study First Received: February 23, 2012
Last Updated: December 13, 2012
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Lung Neoplasms
Gastrointestinal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 23, 2013