Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients
NCT ID: NCT04859400
Last Updated: 2024-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2021-06-07
2024-11-06
Brief Summary
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Detailed Description
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The study desing is a randomized, two-arm and multicenter international trial and advanced lung or gastrointestinal cancer patients not eligible for curative treatment make up the patient population.
Patients in the intervention group receive a nutrition and exercise program in combination with an electronic application for data collection and monitoring.
The nutritional program comprises an extensive nutritional assessment and an individual nutritional recommendation. In addition, patients receive a whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) to support an optimal protein intake in combination with physical activity. The nutritional situation is reassessed at 2 -3 weeks.
Exercise counselling includes at least two visits with an extensive first baseline assessment. On this basis, an individual training program for 12 weeks in a home-based setting is compiled, with mainly strength and endurance exercises. At week 2-3, the patient and the study physiotherapist have a follow-up meeting.
The application Swiss NutriAct is mainly used for data collection (nutritional, exercise and QoL data). Since the study coordinator, dietician and physiotherapist can see the information entered by the intervention group patients, they can contact patients and offer help regarding the nutrition and exercise program, where deemed appropriate. Vice versa, patients can use the help button to contact the study team to ask questions regarding the nutrition and exercise program.
Patients in the control group receive standard of care and a limited version of the application.
Both arms will be assessed at baseline (0 weeks), after the 12 weeks intervention phase and at a follow up assessment after 24 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention
standardized nutritional program including a nutritional supplement
standardized exercise program
app for monitoring.
Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB)
The whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) is ingested once daily, preferably either in the evening before going to bed or within two hours after having finished exercising.
Standardized nutritional program
During at least two personal counseling meetings with a dietician, the patient's diet is assessed and individual nutritional interventions - based on the personal needs and individual preferences of the patient - are developed. The overall goal is to optimize protein an energy intake.
Standardized exercise program
In at least two personal counseling meetings with a physiotherapist, the patient's individual training plan is compiled and agreed upon (mainly including strength, endurance and balance exercises). The patient then exercises at home and records the trainings with the app.
Control
standard of care
limited version of the app (e.g. without the "help" function).
No interventions assigned to this group
Interventions
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Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB)
The whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) is ingested once daily, preferably either in the evening before going to bed or within two hours after having finished exercising.
Standardized nutritional program
During at least two personal counseling meetings with a dietician, the patient's diet is assessed and individual nutritional interventions - based on the personal needs and individual preferences of the patient - are developed. The overall goal is to optimize protein an energy intake.
Standardized exercise program
In at least two personal counseling meetings with a physiotherapist, the patient's individual training plan is compiled and agreed upon (mainly including strength, endurance and balance exercises). The patient then exercises at home and records the trainings with the app.
Eligibility Criteria
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Inclusion Criteria
* WHO performance status of ≤ 2
* Able to perform physical exercise estimated by the treating physician
* Estimated life expectancy of ≥ 6 months
* Patient must give written informed consent
Exclusion Criteria
* Enteral (except oral nutritional supplements) and/or parenteral nutrition within one month
* History of ileus within previous month
* Milk protein allergy
* The patient cannot understand the trial-specific content due to linguistic, psychological or disease reasons
* Age \< 18 years
18 Years
ALL
No
Sponsors
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Krebsforschung Schweiz, Bern, Switzerland
OTHER
Sponser Sport Food AG
UNKNOWN
Leitwert GmbH
UNKNOWN
SNAQ AG
UNKNOWN
Kantonsspital St. Gallen CTU
UNKNOWN
Kantonsspital Winterthur KSW
OTHER
Responsible Party
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Principal Investigators
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Christian Britschgi, PD Dr. med. Dr. phil
Role: PRINCIPAL_INVESTIGATOR
Kantonsspital Winterthur KSW
Locations
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Klinikum Konstanz
Konstanz, , Germany
Spital STS (Simmental-Thun-Saanenland) AG
Thun, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
Countries
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Other Identifiers
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2020-02992
Identifier Type: -
Identifier Source: org_study_id
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