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

Sponsor

Kantonsspital Winterthur KSW (Other)

Overall Status

Recruiting

CT.gov ID

NCT04859400

Collaborator

Krebsforschung Schweiz, Bern, Switzerland (Other), Sponser Sport Food AG (Other), Leitwert GmbH (Other), SNAQ AG (Other), Kantonsspital St. Gallen CTU (Other)

Enrollment

Location

Arms

29.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Gastrointestinal Cancer, Lung Malnutrition	Dietary Supplement: Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) Behavioral: Standardized nutritional program Behavioral: Standardized exercise program	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 7, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention standardized nutritional program including a nutritional supplement standardized exercise program app for monitoring.	Dietary Supplement: 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. 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. Behavioral: 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.
No Intervention: Control standard of care limited version of the app (e.g. without the "help" function).

Arm

Intervention/Treatment

Experimental: Intervention

standardized nutritional program including a nutritional supplement standardized exercise program app for monitoring.

Dietary Supplement: 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.

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.

Behavioral: 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.

No Intervention: Control

standard of care limited version of the app (e.g. without the "help" function).

Outcome Measures

Primary Outcome Measures

QoL [3 Months]
Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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