Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients

Malnutrition Clinical Trial

Official title:

Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04859400
• Other study ID #: 2020-02992
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• Source: Kantonsspital Winterthur KSW
• Contact: Lucia Gafner, Dr. sc. nat.
• Phone: +41 52 266 21 37
• Email: lucia.gafner[@]ksw.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer, Gastrointestinal
• Cancer, Lung
• Gastrointestinal Neoplasms
• Lung Neoplasms
• Malnutrition

Intervention

Dietary Supplement:
• Whey protein supplement high in leucine and ß-hydroxy-ß-methylbutyrate (HMB)
The whey protein supplement high in leucine and ß-hydroxy-ß-methylbutyrate (HMB) is ingested once daily, preferably either in the evening before going to bed or within two hours after having finished exercising.

Behavioral:
• 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.

Locations

Country	Name	City	State
Germany	Medizinisches Versorgungszentrum Taunus GmbH	Bad Homburg
Germany	Klinikum Konstanz	Konstanz
Switzerland	Spital STS (Simmental-Thun-Saanenland) AG	Thun
Switzerland	Kantonsspital Winterthur	Winterthur

Sponsors (6)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW	Kantonsspital St. Gallen CTU, Krebsforschung Schweiz, Bern, Switzerland, Leitwert GmbH, SNAQ AG, Sponser Sport Food AG

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoL	Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)	3 Months
Secondary	Nutritional status	Body weight (in kg), used in combination with body height to calculate BMI (in kg/m2)	3 months
Secondary	Nutritional status	Patient-generated subjective global assessment (PGSGA)	3 months
Secondary	Nutritional status	Bioelectrical impedance analysis (BIA)	3 months
Secondary	Nutritional status	Muscle mass: L3 image of computertomographic (CT) measurements taken in the context of standard cancer therapy (divided by height squared; in cm2/m2)	3 months
Secondary	Nutritional status	Calf circumference (in cm)	3 months
Secondary	Nutritional status	Sarcopenia screening questionnaire SARC-F	3 months
Secondary	Physical function	Handgrip strength (in kg)	3 months
Secondary	Physical function	60 s sit-to-stand test (number of stands)	3 months
Secondary	Physical function	6 minute walk test (in m)	3 months
Secondary	Energy- and protein intake	Data collected with application, Harris-Benedict formula	3 months
Secondary	Fatigue	Questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)	3 months
Secondary	Clinical data	Physical performance status (WHO performance status, grade 0-5)	3 months
Secondary	Clinical data	Tumor stadium	3 months
Secondary	Clinical data	Adverse events grade 3 and 4	3 months
Secondary	Clinical data	Serious adverse events	3 months
Secondary	Clinical data	Unplanned hospital readmissions	3 months
Secondary	Clinical data	Survival	3 months
Secondary	Adherence to the nutritional and exercise program	According to data collected with application	3 months
Secondary	Usability of the new application	Questionnaire mHealth App Usability (MAUQ)	3 months
Secondary	Success of recruitment rate in comparison to former studies	Number of eligible patients, participants, rejections as compared to similar past studies	Through study completion (24 months)