Cancer, GastrointestinalNCT04859400
Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients
A study testing Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB), Standardized nutritional program and Standardized exercise program in people with Cancer, Gastrointestinal and Cancer, Lung, run by Kantonsspital Winterthur KSW at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Gastrointestinal, Cancer, Lung, Malnutrition
- What is being tested?
- Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB), Standardized nutritional program and Standardized exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 7 Jun 2021to 6 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Switzerland2 sites
Spital STS (Simmental-Thun-Saanenland) AG
Thun, 3600
Kantonsspital Winterthur
Winterthur, 8401
About this study
Official title: Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients
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.
Read the 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.
- Conditions
- Cancer, Gastrointestinal, Cancer, Lung, Malnutrition
- Being tested
- Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB), Standardized nutritional program, Standardized exercise program
- Keywords
- Cancer, Palliative, Application, Nutrition, Exercise
- Medical subject headings
- Gastrointestinal Neoplasms, Lung Neoplasms, Malnutrition, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB)Dietary supplement
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 programBehavioural
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 programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | standardized nutritional program including a nutritional supplement
standardized exercise program
app for monitoring. Receives: Dietary Supplement: Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB); Behavioral: Standardized nutritional program; Behavioral: Standardized exercise program |
| Control | No intervention | standard of care limited version of the app (e.g. without the "help" function). |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoL
Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)
Measured: 3 Months
Secondary outcomes (20)
Nutritional status
Body weight (in kg), used in combination with body height to calculate BMI (in kg/m2)
Measured: 3 months
Nutritional status
Patient-generated subjective global assessment (PGSGA)
Measured: 3 months
Nutritional status
Bioelectrical impedance analysis (BIA)
Measured: 3 months
Nutritional status
Muscle mass: L3 image of computertomographic (CT) measurements taken in the context of standard cancer therapy (divided by height squared; in cm2/m2)
Measured: 3 months
Nutritional status
Calf circumference (in cm)
Measured: 3 months
Nutritional status
Sarcopenia screening questionnaire SARC-F
Measured: 3 months
Physical function
Handgrip strength (in kg)
Measured: 3 months
Physical function
60 s sit-to-stand test (number of stands)
Measured: 3 months
Physical function
6 minute walk test (in m)
Measured: 3 months
Energy- and protein intake
Data collected with application, Harris-Benedict formula
Measured: 3 months
Fatigue
Questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Measured: 3 months
Clinical data
Physical performance status (WHO performance status, grade 0-5)
Measured: 3 months
Clinical data
Tumor stadium
Measured: 3 months
Clinical data
Adverse events grade 3 and 4
Measured: 3 months
Clinical data
Serious adverse events
Measured: 3 months
Clinical data
Unplanned hospital readmissions
Measured: 3 months
Clinical data
Survival
Measured: 3 months
Adherence to the nutritional and exercise program
According to data collected with application
Measured: 3 months
Usability of the new application
Questionnaire mHealth App Usability (MAUQ)
Measured: 3 months
Success of recruitment rate in comparison to former studies
Number of eligible patients, participants, rejections as compared to similar past studies
Measured: Through study completion (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start7 Jun 2021
- Primary completion12 Sep 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, GastrointestinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Collaborators
- Krebsforschung Schweiz, Bern, Switzerland, Sponser Sport Food AG, Leitwert GmbH, SNAQ AG, Cantonal Hospital of St. Gallen
- Responsible party
- Sponsor
- Investigators
- Christian Britschgi, PD Dr. med. Dr. phil, Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859400
- Sponsor's protocol ID
- 2020-02992
- Status last verified
- Nov 2024
- First submitted
- 8 Apr 2021
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients
- ClinicalTrials.gov ID
- NCT04859400
- Acronym / sponsor ID
- 2020-02992
- Conditions
- Cancer, Gastrointestinal, Cancer, Lung, Malnutrition
- Keywords
- Cancer, Palliative, Application, Nutrition, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Collaborators
- Krebsforschung Schweiz, Bern, Switzerland, Sponser Sport Food AG, Leitwert GmbH, SNAQ AG, Cantonal Hospital of St. Gallen
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB), Behavioral: Standardized nutritional program, Behavioral: Standardized exercise programstandardized nutritional program including a nutritional supplement standardized exercise program app for monitoring. |
| Control | No intervention | –standard of care limited version of the app (e.g. without the "help" function). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Intervention |
| Standardized nutritional programDuring 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. | Behavioural | Intervention |
| Standardized exercise programIn 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. | Behavioural | Intervention |
Primary outcome
QoL
Time frame: 3 Months
Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)
20 secondary outcomes
Nutritional status
Time frame: 3 months
Nutritional status
Time frame: 3 months
Nutritional status
Time frame: 3 months
Nutritional status
Time frame: 3 months
Nutritional status
Time frame: 3 months
Nutritional status
Time frame: 3 months
Physical function
Time frame: 3 months
Physical function
Time frame: 3 months
Physical function
Time frame: 3 months
Energy- and protein intake
Time frame: 3 months
Fatigue
Time frame: 3 months
Clinical data
Time frame: 3 months
Clinical data
Time frame: 3 months
Clinical data
Time frame: 3 months
Clinical data
Time frame: 3 months
Clinical data
Time frame: 3 months
Clinical data
Time frame: 3 months
Adherence to the nutritional and exercise program
Time frame: 3 months
Usability of the new application
Time frame: 3 months
Success of recruitment rate in comparison to former studies
Time frame: Through study completion (24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) with other researchers.
Related trials for Cancer, Gastrointestinal
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Britschgi, PD Dr. med. Dr. phil principal investigator
Kantonsspital Winterthur KSW
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB), Standardized nutritional program and Standardized exercise program in people with Cancer, Gastrointestinal and Cancer, Lung, run by Kantonsspital Winterthur KSW at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoL (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.