NCT04859400

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

June 7, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2024

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

3.3 years

First QC Date

April 8, 2021

Last Update Submit

November 7, 2024

Conditions

Cancer, GastrointestinalCancer, LungMalnutrition

Keywords

CancerPalliativeApplicationNutritionExercise

Outcome Measures

Primary Outcomes (1)

  • QoL

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

    3 Months

Secondary Outcomes (20)

  • Nutritional status

    3 months

  • Nutritional status

    3 months

  • Nutritional status

    3 months

  • Nutritional status

    3 months

  • Nutritional status

    3 months

  • +15 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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)Behavioral: Standardized nutritional programBehavioral: Standardized exercise program

Control

NO INTERVENTION

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

Interventions

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.

Intervention
Standardized nutritional programBEHAVIORAL

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
Standardized exercise programBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klinikum Konstanz

Konstanz, 78464, Germany

Location

Spital STS (Simmental-Thun-Saanenland) AG

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

MeSH Terms

Conditions

Gastrointestinal NeoplasmsLung NeoplasmsMalnutritionNeoplasmsMotor Activity

Interventions

Leucine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNutrition DisordersNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Christian Britschgi, PD Dr. med. Dr. phil

    Kantonsspital Winterthur KSW

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 26, 2021

Study Start

June 7, 2021

Primary Completion

September 12, 2024

Study Completion

November 6, 2024

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data (IPD) with other researchers.

Locations

DE(1)CH(2)