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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malnutrition; Cancer, Lung; Cancer, Gastrointestinal
• Intervention / Treatment: Dietary supplement: Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB); Behavioral: Standardized nutritional program; Behavioral: Standardized exercise program

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucia Gafner, Dr. sc. nat.; Phone Number: +41 52 266 21 37; Email: lucia.gafner@ksw.ch
• Study Contact Backup: Name: Lena Storck, Dr. rer. med.; Phone Number: +41 52 266 23 27; Email: lena.storck@ksw.ch

Study Locations

• Germany
  • Bad Homburg, Germany, 61352
    • Not yet recruiting
    • Medizinisches Versorgungszentrum Taunus GmbH
    • Contact: Acimic Christina; Phone Number: +49 (0) 6172 14 - 3870; Email: christina.acimic@hochtaunus-kliniken.de
    • Principal Investigator: Migle Link, Dr. med.
  • Konstanz, Germany, 78464
    • Recruiting
    • Klinikum Konstanz
    • Contact: Lena J Storck, Dr. (rer.) med.; Phone Number: +49 (0) 7531 801 12-40; Email: Lena.Storck@glkn.de
    • Principal Investigator: Yvonne Krepp, Dr. med.
• Switzerland
  • Thun, Switzerland, 3600
    • Recruiting
    • Spital STS (Simmental-Thun-Saanenland) AG
    • Contact: Barbara Rohrbach; Phone Number: +41 (0)58 636 22 27; Email: barbara.rohrbach@spitalstsag.ch
    • Principal Investigator: Christoph Ackermann, Dr. med.
  • Winterthur, Switzerland, 8401
    • Recruiting
    • Kantonsspital Winterthur
    • Contact: Lucia Gafner, Dr. sc. nat.; Phone Number: +41 52 266 21 37; Email: lucia.gafner@ksw.ch
    • Contact: Lena J. Storck, Dr. (rer.) med.; Phone Number: +41 52 266 23 27; Email: lena.storck@ksw.ch
    • Principal Investigator: Miklos Pless, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QoL	Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status	Body weight (in kg), used in combination with body height to calculate BMI (in kg/m2)	3 months
Nutritional status	Patient-generated subjective global assessment (PGSGA)	3 months
Nutritional status	Bioelectrical impedance analysis (BIA)	3 months
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
Nutritional status	Calf circumference (in cm)	3 months
Nutritional status	Sarcopenia screening questionnaire SARC-F	3 months
Physical function	Handgrip strength (in kg)	3 months
Physical function	60 s sit-to-stand test (number of stands)	3 months
Physical function	6 minute walk test (in m)	3 months
Energy- and protein intake	Data collected with application, Harris-Benedict formula	3 months
Fatigue	Questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)	3 months
Clinical data	Physical performance status (WHO performance status, grade 0-5)	3 months
Clinical data	Tumor stadium	3 months
Clinical data	Adverse events grade 3 and 4	3 months
Clinical data	Serious adverse events	3 months
Clinical data	Unplanned hospital readmissions	3 months
Clinical data	Survival	3 months
Adherence to the nutritional and exercise program	According to data collected with application	3 months
Usability of the new application	Questionnaire mHealth App Usability (MAUQ)	3 months
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)

Collaborators and Investigators

• Sponsor: Kantonsspital Winterthur KSW
• Collaborators: Krebsforschung Schweiz, Bern, Switzerland; Sponser Sport Food AG; Leitwert GmbH; SNAQ AG; Kantonsspital St. Gallen CTU
• Investigators: Principal Investigator: Miklos Pless, Prof. Dr. med., Kantonsspital Winterthur KSW

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Cancer; Nutrition; Application; Palliative
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Nutrition Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Gastrointestinal Neoplasms; Malnutrition
• Other Study ID Numbers: 2020-02992

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data (IPD) with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No