Influence of a home-based nutrition and exercise program incorporating an app on the quality of life of outpatient palliative cancer patients
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
- Supportive nutritional therapy (enteral nutrition, parenteral nutrition) in the last month - Acute intestinal obstruction in the last month - Allergy to milk protein (BASEC)
Luogo dello studio
Winterthur, Altro
(BASEC)
Thun
(BASEC)
Sponsor
Kantonsspital Winterthur
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. med. Dr. phil. Christian Britschgi
+41 52 266 36 58
christian.britschgi@clutterksw.chKlinik für med. Onkologie und Hämatologie, Kantonsspital Winterthur
(BASEC)
Informazioni generali
Kantonsspital Winterthur KSW
(ICTRP)
Informazioni scientifiche
Kantonsspital Winterthur KSW
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
30.03.2021
(BASEC)
ID di studio ICTRP
NCT04859400 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Influence of a home-based nutrition and exercise program including an application for monitoring on quality of life in advanced cancer outpatients (BASEC)
Titolo accademico
Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients (ICTRP)
Titolo pubblico
Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients (ICTRP)
Malattie studiate
Cancer, Gastrointestinal;Cancer, Lung;Malnutrition (ICTRP)
Intervento studiato
Dietary Supplement: Whey protein supplement high in leucine and ?-hydroxy-?-methylbutyrate (HMB);Behavioral: Standardized nutritional program;Behavioral: Standardized exercise program (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Krebsforschung Schweiz, Bern, Switzerland;Sponser Sport Food AG;Leitwert GmbH;SNAQ AG;Kantonsspital St. Gallen CTU (ICTRP)
Contatti aggiuntivi
Christian Britschgi, PD Dr. med. Dr. phil, Kantonsspital Winterthur KSW (ICTRP)
ID secondari
2020-02992 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04859400 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile