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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04859400
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : August 19, 2022
Sponsor:
Collaborators:
Krebsforschung Schweiz, Bern, Switzerland
Sponser Sport Food AG
Leitwert GmbH
SNAQ AG
Kantonsspital St. Gallen CTU
Information provided by (Responsible Party):
Kantonsspital Winterthur KSW

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 7, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. QoL [ Time Frame: 3 Months ]
    Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)


Secondary Outcome Measures :
  1. Nutritional status [ Time Frame: 3 months ]
    Body weight (in kg), used in combination with body height to calculate BMI (in kg/m2)

  2. Nutritional status [ Time Frame: 3 months ]
    Patient-generated subjective global assessment (PGSGA)

  3. Nutritional status [ Time Frame: 3 months ]
    Bioelectrical impedance analysis (BIA)

  4. Nutritional status [ Time Frame: 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)

  5. Nutritional status [ Time Frame: 3 months ]
    Calf circumference (in cm)

  6. Nutritional status [ Time Frame: 3 months ]
    Sarcopenia screening questionnaire SARC-F

  7. Physical function [ Time Frame: 3 months ]
    Handgrip strength (in kg)

  8. Physical function [ Time Frame: 3 months ]
    60 s sit-to-stand test (number of stands)

  9. Physical function [ Time Frame: 3 months ]
    6 minute walk test (in m)

  10. Energy- and protein intake [ Time Frame: 3 months ]
    Data collected with application, Harris-Benedict formula

  11. Fatigue [ Time Frame: 3 months ]
    Questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

  12. Clinical data [ Time Frame: 3 months ]
    Physical performance status (WHO performance status, grade 0-5)

  13. Clinical data [ Time Frame: 3 months ]
    Tumor stadium

  14. Clinical data [ Time Frame: 3 months ]
    Adverse events grade 3 and 4

  15. Clinical data [ Time Frame: 3 months ]
    Serious adverse events

  16. Clinical data [ Time Frame: 3 months ]
    Unplanned hospital readmissions

  17. Clinical data [ Time Frame: 3 months ]
    Survival

  18. Adherence to the nutritional and exercise program [ Time Frame: 3 months ]
    According to data collected with application

  19. Usability of the new application [ Time Frame: 3 months ]
    Questionnaire mHealth App Usability (MAUQ)

  20. Success of recruitment rate in comparison to former studies [ Time Frame: Through study completion (24 months) ]
    Number of eligible patients, participants, rejections as compared to similar past studies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04859400


Contacts
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Contact: Lucia Gafner, Dr. sc. nat. +41 52 266 21 37 lucia.gafner@ksw.ch
Contact: Lena Storck, Dr. rer. med. +41 52 266 23 27 lena.storck@ksw.ch

Locations
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Switzerland
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, 8401
Contact: Lucia Gafner, Dr. sc. nat.    +41 52 266 21 37    lucia.gafner@ksw.ch   
Contact: Lena J. Storck, Dr. (rer.) med.    +41 52 266 23 27    lena.storck@ksw.ch   
Principal Investigator: Miklos Pless, Prof. Dr. med.         
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Krebsforschung Schweiz, Bern, Switzerland
Sponser Sport Food AG
Leitwert GmbH
SNAQ AG
Kantonsspital St. Gallen CTU
Investigators
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Principal Investigator: Miklos Pless, Prof. Dr. med. Kantonsspital Winterthur KSW
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Responsible Party: Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT04859400    
Other Study ID Numbers: 2020-02992
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data (IPD) with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kantonsspital Winterthur KSW:
Cancer
Palliative
Application
Nutrition
Exercise
Additional relevant MeSH terms:
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Lung Neoplasms
Gastrointestinal Neoplasms
Malnutrition
Nutrition Disorders
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases