NCT03274349

Brief Summary

The objective or the trial is to study the influence of a combined therapy involving protein-rich individualized nutritional therapy and highly effective muscle training via personalized whole-body electromyostimulation exercise on muscle mass, muscle functionality, physical capability, fatigue and quality of life in patients with esophageal and bronchial carcinoma in advanced or metastatic stage.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

4 years

First QC Date

May 30, 2017

Last Update Submit

October 15, 2018

Conditions

Cancer of EsophagusCancer, Lung

Outcome Measures

Primary Outcomes (1)

  • Muscle mass maintenance or increase, as assessed by Bioelectrical Impedance Analysis

    Maintenance or increase of skeletal muscle mass in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS, by assessing Bioelectrical Impedance Analysis values.

    12 weeks per patient

Secondary Outcomes (6)

  • Increase in quality of life score by assessing the score points using EORTC-QLQ-C30 questionnaires

    12 weeks per patient

  • Increase or maintenance of muscle strength, as assessed by hand grip strength measurements (Jamar dynamometry)

    12 weeks per patient

  • Improvement of pain scores, as assessed by Visual Analog Score

    12 weeks per patient

  • Improvement of fatigue scores, as assessed by FACIT-Fatigue Score

    12 weeks per patient

  • Improvement of oncological therapy tolerance, as assessed by Common Toxicity Criteria regarding gastrointestinal complaints

    12 weeks per patient

  • +1 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Group of patients receiving individualized protein-rich nutritional therapy without exercise, 12 weeks intervention per patient

Procedure: protein-rich nutrition therapy

EMS-group

EXPERIMENTAL

Group of patients receiving individualized protein-rich nutritional therapy with personalized whole body electromyostimulation exercise, 12 weeks intervention per patient

Procedure: whole body electromyostimulation exerciseProcedure: protein-rich nutrition therapy

Interventions

whole body electromyostimulation exercisePROCEDURE

whole body electromyostimulation exercise training twice a week for 20 min each, bipolar, 85 Hz, intermittent pulse/pause, pulse width 350 µsec

EMS-group
protein-rich nutrition therapyPROCEDURE

protein-rich nutrition therapy with an objective of reaching 1,2 to 1,5 g protein/kg body weight and day

ControlEMS-group

Eligibility Criteria

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

You may qualify if:

  • Patients with esophageal and/or bronchial carcinoma in curative or palliative treatment

You may not qualify if:

  • Healthy persons or patients under age
  • Pregnancy, Lactation
  • Psychological disorders, epilepsia, sever neurological disorders
  • Participation in other exercise- or nutrition studies within the last 6 months
  • Acute cardiovascular disease
  • Rheuma
  • Intake of anabolic drugs,
  • Skin injuries in the area of electrode placements
  • Electronic implants (defibrillator, pacemaker)
  • Persons in mental hospitals by order of authorities or jurisdiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Erlangen, Department of Medicine 1

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Esophageal NeoplasmsLung Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yurdaguel Zopf, Prof.

    University Erlangen Nuremberg Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yurdaguel Zopf, Prof.

CONTACT

*49 9131 85-35000yurdaguel.zopf@uk-erlangen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The patients will be coded by a consecutive numbering. Data will be saved only with this number. Access to the data will only be provided to authorized personnel (study nurses) and will be retained in inaccessable and locked rooms.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, controlled pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2017

First Posted

September 6, 2017

Study Start

March 17, 2017

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

October 16, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)