Clinical trial NCT04859400: Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients
Official title: Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Gastrointestinal
Cancer, Lung
Malnutrition
Keywords: Cancer
Palliative
Application
Nutrition
Exercise
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
Collaborators: name: Krebsforschung Schweiz, Bern, Switzerland
name: Sponser Sport Food AG
name: Leitwert GmbH
name: SNAQ AG
name: Kantonsspital St. Gallen CTU
First posted: 2021-04-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main purpose of the study is to investigate whether a tailor-made nutritional and exercise program including home-based sessions and regular monitoring using an application on the smartphone is effective in improving Quality of Life in patients with advanced lung or gastrointestinal tract cancer.

Detailed description: Cachexia is highly prevalent among cancer patients and has substantial impact on the Quality of Life (QoL) and the functional status of patients.Therefore, the main purpose of this study is to investigate whether a mainly home-based nutritional and exercise program including regular monitoring using an application on the smartphone is effective in improving QoL in patients with advanced lung or gastrointestinal tract cancer.

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.

Eligibility criteria: 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

Primary outcomes:
measure: QoL
timeFrame: 3 Months
Secondary outcomes:
measure: Nutritional status
timeFrame: 3 months
measure: Nutritional status
timeFrame: 3 months
measure: Nutritional status
timeFrame: 3 months
measure: Nutritional status
timeFrame: 3 months
measure: Nutritional status
timeFrame: 3 months
measure: Nutritional status
timeFrame: 3 months
measure: Physical function
timeFrame: 3 months
measure: Physical function
timeFrame: 3 months
measure: Physical function
timeFrame: 3 months
measure: Energy- and protein intake
timeFrame: 3 months
measure: Fatigue
timeFrame: 3 months
measure: Clinical data
timeFrame: 3 months
measure: Clinical data
timeFrame: 3 months
measure: Clinical data
timeFrame: 3 months
measure: Clinical data
timeFrame: 3 months
measure: Clinical data
timeFrame: 3 months
measure: Clinical data
timeFrame: 3 months
measure: Adherence to the nutritional and exercise program
timeFrame: 3 months
measure: Usability of the new application
timeFrame: 3 months
measure: Success of recruitment rate in comparison to former studies
timeFrame: Through study completion (24 months)
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: Klinikum Konstanz
city: Thun
country: Switzerland
facility: Spital STS (Simmental-Thun-Saanenland) AG
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Christian Britschgi, PD Dr. med. Dr. phil
role: PRINCIPAL_INVESTIGATOR
References: