Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients
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| ClinicalTrials.gov Identifier: NCT04859400 |
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Recruitment Status :
Recruiting
First Posted : April 26, 2021
Last Update Posted : August 19, 2022
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| 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 |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
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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. |
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No Intervention: Control
standard of care limited version of the app (e.g. without the "help" function). |
- QoL [ Time Frame: 3 Months ]Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)
- Nutritional status [ Time Frame: 3 months ]Body weight (in kg), used in combination with body height to calculate BMI (in kg/m2)
- Nutritional status [ Time Frame: 3 months ]Patient-generated subjective global assessment (PGSGA)
- Nutritional status [ Time Frame: 3 months ]Bioelectrical impedance analysis (BIA)
- 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)
- Nutritional status [ Time Frame: 3 months ]Calf circumference (in cm)
- Nutritional status [ Time Frame: 3 months ]Sarcopenia screening questionnaire SARC-F
- Physical function [ Time Frame: 3 months ]Handgrip strength (in kg)
- Physical function [ Time Frame: 3 months ]60 s sit-to-stand test (number of stands)
- Physical function [ Time Frame: 3 months ]6 minute walk test (in m)
- Energy- and protein intake [ Time Frame: 3 months ]Data collected with application, Harris-Benedict formula
- Fatigue [ Time Frame: 3 months ]Questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
- Clinical data [ Time Frame: 3 months ]Physical performance status (WHO performance status, grade 0-5)
- Clinical data [ Time Frame: 3 months ]Tumor stadium
- Clinical data [ Time Frame: 3 months ]Adverse events grade 3 and 4
- Clinical data [ Time Frame: 3 months ]Serious adverse events
- Clinical data [ Time Frame: 3 months ]Unplanned hospital readmissions
- Clinical data [ Time Frame: 3 months ]Survival
- Adherence to the nutritional and exercise program [ Time Frame: 3 months ]According to data collected with application
- Usability of the new application [ Time Frame: 3 months ]Questionnaire mHealth App Usability (MAUQ)
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
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
| 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 |
| 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. | |
| Principal Investigator: | Miklos Pless, Prof. Dr. med. | Kantonsspital Winterthur KSW |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cancer Palliative Application Nutrition Exercise |
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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 |