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.
2 other identifiers
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2012
CompletedFirst Posted
Study publicly available on registry
February 29, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJune 26, 2015
June 1, 2015
3 years
February 23, 2012
June 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of life
3 months
Study Arms (2)
Nutrition & physical exercise
EXPERIMENTALControl
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kantonsspital Winterthur
Winterthur, 8401, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter E. Ballmer, Prof. Dr.
Kantonsspital Winterthur KSW
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2012
First Posted
February 29, 2012
Study Start
March 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
June 26, 2015
Record last verified: 2015-06