Nutrition and Physical Exercise Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier:
NCT01540968
First received: February 23, 2012
Last updated: February 23, 2015
Last verified: February 2015
  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:


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: August 2015
Estimated Primary Completion Date: March 2015 (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
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, see Learn About Clinical Studies.

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

Locations
Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
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: February 23, 2015
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on April 23, 2015