JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04859400

Studienbeginn:
Juni 2021

Letztes Update:
06.10.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Lung Neoplasms, Gastrointestinal Neoplasms, Malnutrition

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Kantonsspital Winterthur KSW

Collaborator:
Krebsforschung Schweiz, Bern, Switzerland, Sponser Sport Food AG, Leitwert GmbH, SNAQ AG, Kantonsspital St. Gallen CTU,

Studienleiter

Miklos Pless, Prof. Dr. med.
Principal Investigator
Kantonsspital Winterthur KSW

Kontakt

Lucia Gafner, Dr. sc. nat.
Kontakt:
Phone: +41 52 266 21 37
E-Mail: lucia.gafner@ksw.ch» Kontaktdaten anzeigen

Lena Storck, Dr. rer. med.
Kontakt:
Phone: +41 52 266 23 27
E-Mail: lena.storck@ksw.ch» Kontaktdaten anzeigen

Studienlocations
(3 von 4)

Medizinisches Versorgungszentrum Taunus GmbH
61352 Bad Homburg
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Acimic Christina
Phone: +49 (0) 6172 14 - 3870
E-Mail: christina.acimic@hochtaunus-kliniken.de» Ansprechpartner anzeigen

Klinikum Konstanz
78464 Konstanz
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Lena J Storck, Dr. (rer.) med.
Phone: +49 (0) 7531 801 12-40
E-Mail: Lena.Storck@glkn.de» Ansprechpartner anzeigen

Spital STS (Simmental-Thun-Saanenland) AG
3600 Thun
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Barbara Rohrbach
Phone: +41 (0)58 636 22 27
E-Mail: barbara.rohrbach@spitalstsag.ch» Ansprechpartner anzeigen

Kantonsspital Winterthur
8401 Winterthur
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Lucia Gafner, Dr. sc. nat.
Phone: +41 52 266 21 37
E-Mail: lucia.gafner@ksw.ch

Lena J. Storck, Dr. (rer.) med.
Phone: +41 52 266 23 27
E-Mail: lena.storck@ksw.ch» Ansprechpartner anzeigen

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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

Secondary outcome:

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

Studien-Arme

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

Geprüfte Regime

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.
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.

Quelle: ClinicalTrials.gov

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