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

Kantonsspital Winterthur KSW

Status: Completed

Conditions: Cancer, Lung; Malnutrition; Cancer, Gastrointestinal

Treatments: Behavioral: Standardized nutritional program; Dietary Supplement: Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB); Behavioral: Standardized exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT04859400

2020-02992

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Standardized exercise program

Dietary Supplement: Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB)

Behavioral: Standardized nutritional program

Control

No Intervention group

Description:

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