Influence of a home-based nutrition and exercise program incorporating an app on the quality of life of outpatient palliative cancer patients
Summary description of the study
We want to investigate in this study whether a combined exercise and nutrition program with a dietary supplement and a smartphone app has an impact on the personal quality of life of patients. Furthermore, we want to examine whether our therapy program can optimize nutritional status, muscle mass, physical performance, as well as energy and protein intake. Additionally, we would like to study the impact of these measures on fatigue and the clinical course of patients. We are also interested in how well patients adhere to the program and how many patients participate in the study.
(BASEC)
Intervention under investigation
The intervention group receives, in addition to regular medical treatment, nutritional therapy support through dietary counseling and professional, progressive physical training through physiotherapy, which is supported by the intake of a supplemental drink. Additionally, study participants receive an app for their smartphone, allowing them to store data and contact the study team.
(BASEC)
Disease under investigation
Patients with tumor disease in the lung or gastrointestinal tract who are not treated curatively.
(BASEC)
- Individuals with a tumor in the lung or gastrointestinal tract who are not treated curatively - Able to engage in physical activity - Able to understand the relevant information and texts for the study (BASEC)
Exclusion criteria
- Supportive nutritional therapy (enteral nutrition, parenteral nutrition) in the last month - Acute intestinal obstruction in the last month - Allergy to milk protein (BASEC)
Trial sites
Winterthur, Other
(BASEC)
Thun
(BASEC)
Sponsor
Kantonsspital Winterthur
(BASEC)
Contact
Contact Person Switzerland
Dr. med. Dr. phil. Christian Britschgi
+41 52 266 36 58
christian.britschgi@clutterksw.chKlinik für med. Onkologie und Hämatologie, Kantonsspital Winterthur
(BASEC)
General Information
Kantonsspital Winterthur KSW
(ICTRP)
Scientific Information
Kantonsspital Winterthur KSW
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
30.03.2021
(BASEC)
ICTRP Trial ID
NCT04859400 (ICTRP)
Official title (approved by ethics committee)
Influence of a home-based nutrition and exercise program including an application for monitoring on quality of life in advanced cancer outpatients (BASEC)
Academic title
Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients (ICTRP)
Public title
Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients (ICTRP)
Disease under investigation
Cancer, Gastrointestinal;Cancer, Lung;Malnutrition (ICTRP)
Intervention under investigation
Dietary Supplement: Whey protein supplement high in leucine and ?-hydroxy-?-methylbutyrate (HMB);Behavioral: Standardized nutritional program;Behavioral: Standardized exercise program (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Advanced lung or gastrointestinal cancer patients not eligible for curative
treatment
- 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:
- Intake of supplements with high-dose branched-chain amino acids within one month
- 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 (ICTRP)
not available
Primary and secondary end points
QoL (ICTRP)
Nutritional status;Nutritional status;Nutritional status;Nutritional status;Nutritional status;Nutritional status;Physical function;Physical function;Physical function;Energy- and protein intake;Fatigue;Clinical data;Clinical data;Clinical data;Clinical data;Clinical data;Clinical data;Adherence to the nutritional and exercise program;Usability of the new application;Success of recruitment rate in comparison to former studies (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Krebsforschung Schweiz, Bern, Switzerland;Sponser Sport Food AG;Leitwert GmbH;SNAQ AG;Kantonsspital St. Gallen CTU (ICTRP)
Additional contacts
Christian Britschgi, PD Dr. med. Dr. phil, Kantonsspital Winterthur KSW (ICTRP)
Secondary trial IDs
2020-02992 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04859400 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available