Back to resultsNutrition and Physical Exercise Study
Primary Purpose
Gastrointestinal Cancer, Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Nutrition & physical exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Gastrointestinal Cancer
Eligibility 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
Sites / Locations
- Kantonsspital Winterthur
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutrition & physical exercise
Control
Arm Description
Outcomes
Primary Outcome Measures
Quality of life
Secondary Outcome Measures
Full Information
NCT ID
NCT01540968
First Posted
February 23, 2012
Last Updated
June 25, 2015
Sponsor
Kantonsspital Winterthur KSW
1. Study Identification
Unique Protocol Identification Number
NCT01540968
Brief Title
Nutrition and Physical Exercise Study
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kantonsspital Winterthur KSW
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer, Lung Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrition & physical exercise
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Nutrition & physical exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter E. Ballmer, Prof. Dr.
Organizational Affiliation
Kantonsspital Winterthur KSW
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Nutrition and Physical Exercise Study
We'll reach out to this number within 24 hrs