- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01540968
Nutrition and Physical Exercise Study
June 25, 2015 updated by: Kantonsspital Winterthur KSW
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Winterthur, Switzerland, 8401
- Kantonsspital Winterthur
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
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Experimental: Nutrition & physical exercise
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life
Time Frame: 3 months
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Peter E. Ballmer, Prof. Dr., Kantonsspital Winterthur KSW
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
February 23, 2012
First Submitted That Met QC Criteria
February 28, 2012
First Posted (Estimate)
February 29, 2012
Study Record Updates
Last Update Posted (Estimate)
June 26, 2015
Last Update Submitted That Met QC Criteria
June 25, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-Nr. 2011-0447
- KFS-2833-08-2011 (Other Grant/Funding Number: Krebsforschung Schweiz / Krebsliga Schweiz)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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