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

Primary Purpose

Cancer, Gastrointestinal, Cancer, Lung, Malnutrition

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB)
Standardized nutritional program
Standardized exercise program
Sponsored by
Kantonsspital Winterthur KSW
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer, Gastrointestinal focused on measuring Cancer, Palliative, Application, Nutrition, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medizinisches Versorgungszentrum Taunus GmbH
  • Klinikum KonstanzRecruiting
  • Spital STS (Simmental-Thun-Saanenland) AGRecruiting
  • Kantonsspital WinterthurRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

QoL
Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)

Secondary Outcome Measures

Nutritional status
Body weight (in kg), used in combination with body height to calculate BMI (in kg/m2)
Nutritional status
Patient-generated subjective global assessment (PGSGA)
Nutritional status
Bioelectrical impedance analysis (BIA)
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)
Nutritional status
Calf circumference (in cm)
Nutritional status
Sarcopenia screening questionnaire SARC-F
Physical function
Handgrip strength (in kg)
Physical function
60 s sit-to-stand test (number of stands)
Physical function
6 minute walk test (in m)
Energy- and protein intake
Data collected with application, Harris-Benedict formula
Fatigue
Questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Clinical data
Physical performance status (WHO performance status, grade 0-5)
Clinical data
Tumor stadium
Clinical data
Adverse events grade 3 and 4
Clinical data
Serious adverse events
Clinical data
Unplanned hospital readmissions
Clinical data
Survival
Adherence to the nutritional and exercise program
According to data collected with application
Usability of the new application
Questionnaire mHealth App Usability (MAUQ)
Success of recruitment rate in comparison to former studies
Number of eligible patients, participants, rejections as compared to similar past studies

Full Information

First Posted
April 8, 2021
Last Updated
October 5, 2023
Sponsor
Kantonsspital Winterthur KSW
Collaborators
Krebsforschung Schweiz, Bern, Switzerland, Sponser Sport Food AG, Leitwert GmbH, SNAQ AG, Kantonsspital St. Gallen CTU
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1. Study Identification

Unique Protocol Identification Number
NCT04859400
Brief Title
Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients
Official Title
Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kantonsspital Winterthur KSW
Collaborators
Krebsforschung Schweiz, Bern, Switzerland, Sponser Sport Food AG, Leitwert GmbH, SNAQ AG, Kantonsspital St. Gallen CTU

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Gastrointestinal, Cancer, Lung, Malnutrition
Keywords
Cancer, Palliative, Application, Nutrition, Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
standardized nutritional program including a nutritional supplement standardized exercise program app for monitoring.
Arm Title
Control
Arm Type
No Intervention
Arm Description
standard of care limited version of the app (e.g. without the "help" function).
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standardized nutritional program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standardized exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
QoL
Description
Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Nutritional status
Description
Body weight (in kg), used in combination with body height to calculate BMI (in kg/m2)
Time Frame
3 months
Title
Nutritional status
Description
Patient-generated subjective global assessment (PGSGA)
Time Frame
3 months
Title
Nutritional status
Description
Bioelectrical impedance analysis (BIA)
Time Frame
3 months
Title
Nutritional status
Description
Muscle mass: L3 image of computertomographic (CT) measurements taken in the context of standard cancer therapy (divided by height squared; in cm2/m2)
Time Frame
3 months
Title
Nutritional status
Description
Calf circumference (in cm)
Time Frame
3 months
Title
Nutritional status
Description
Sarcopenia screening questionnaire SARC-F
Time Frame
3 months
Title
Physical function
Description
Handgrip strength (in kg)
Time Frame
3 months
Title
Physical function
Description
60 s sit-to-stand test (number of stands)
Time Frame
3 months
Title
Physical function
Description
6 minute walk test (in m)
Time Frame
3 months
Title
Energy- and protein intake
Description
Data collected with application, Harris-Benedict formula
Time Frame
3 months
Title
Fatigue
Description
Questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Time Frame
3 months
Title
Clinical data
Description
Physical performance status (WHO performance status, grade 0-5)
Time Frame
3 months
Title
Clinical data
Description
Tumor stadium
Time Frame
3 months
Title
Clinical data
Description
Adverse events grade 3 and 4
Time Frame
3 months
Title
Clinical data
Description
Serious adverse events
Time Frame
3 months
Title
Clinical data
Description
Unplanned hospital readmissions
Time Frame
3 months
Title
Clinical data
Description
Survival
Time Frame
3 months
Title
Adherence to the nutritional and exercise program
Description
According to data collected with application
Time Frame
3 months
Title
Usability of the new application
Description
Questionnaire mHealth App Usability (MAUQ)
Time Frame
3 months
Title
Success of recruitment rate in comparison to former studies
Description
Number of eligible patients, participants, rejections as compared to similar past studies
Time Frame
Through study completion (24 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Gafner, Dr. sc. nat.
Phone
+41 52 266 21 37
Email
lucia.gafner@ksw.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Lena Storck, Dr. rer. med.
Phone
+41 52 266 23 27
Email
lena.storck@ksw.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miklos Pless, Prof. Dr. med.
Organizational Affiliation
Kantonsspital Winterthur KSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinisches Versorgungszentrum Taunus GmbH
City
Bad Homburg
ZIP/Postal Code
61352
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Acimic Christina
Phone
+49 (0) 6172 14 - 3870
Email
christina.acimic@hochtaunus-kliniken.de
First Name & Middle Initial & Last Name & Degree
Migle Link, Dr. med.
Facility Name
Klinikum Konstanz
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena J Storck, Dr. (rer.) med.
Phone
+49 (0) 7531 801 12-40
Email
Lena.Storck@glkn.de
First Name & Middle Initial & Last Name & Degree
Yvonne Krepp, Dr. med.
Facility Name
Spital STS (Simmental-Thun-Saanenland) AG
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Rohrbach
Phone
+41 (0)58 636 22 27
Email
barbara.rohrbach@spitalstsag.ch
First Name & Middle Initial & Last Name & Degree
Christoph Ackermann, Dr. med.
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucia Gafner, Dr. sc. nat.
Phone
+41 52 266 21 37
Email
lucia.gafner@ksw.ch
First Name & Middle Initial & Last Name & Degree
Lena J. Storck, Dr. (rer.) med.
Phone
+41 52 266 23 27
Email
lena.storck@ksw.ch
First Name & Middle Initial & Last Name & Degree
Miklos Pless, Prof. Dr. med.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data (IPD) with other researchers.

Learn more about this trial

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

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