Cancer, Gastrointestinal, Cancer, Lung, Malnutrition
Conditions
Keywords
Cancer, Palliative, Application, Nutrition, Exercise
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.
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.
Interventions
DIETARY_SUPPLEMENTWhey 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.
BEHAVIORALStandardized 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.
BEHAVIORALStandardized 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.
Sponsors
Krebsforschung Schweiz, Bern, Switzerland
Sponser Sport Food AG
Leitwert GmbH
SNAQ AG
Cantonal Hospital of St. Gallen
Kantonsspital Winterthur KSW
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoL | 3 Months | Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Nutritional status | 3 months | Body weight (in kg), used in combination with body height to calculate BMI (in kg/m2) |
| Clinical data | 3 months | Physical performance status (WHO performance status, grade 0-5) |
| 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) |
| 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 |
| Physical function | 3 months | Handgrip strength (in kg) |
Countries
Germany, Switzerland
Outcome results
None listed