NCT02585362

Brief Summary

This study evaluates physical performance in cancer outpatients during a multimodal therapy. Half of the patients will receive physical exercise und nutrition program in combination with a specially formulated whey protein supplement, while the other half will receive standard care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

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

October 13, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

2.6 years

First QC Date

October 13, 2015

Last Update Submit

January 10, 2019

Conditions

Lung CancerGastro-Intestinal CancerBreast CancerProstate CancerPleural MesotheliomaUrothelial CarcinomaRenal Cell CarcinomaOvarian Cancer

Keywords

palliative

Outcome Measures

Primary Outcomes (1)

  • Change in physical performance

    Physical performance will be assessed with the short physical performance battery

    measured at week 0, 12 and 24

Secondary Outcomes (9)

  • Change in body composition

    measured at week 0, 12 and 24

  • Change in quality of life

    measured at week 0, 12 and 24

  • Change in fatigue

    measured at week 0, 12 and 24

  • Change in physical function

    measured at week 0, 12 and 24

  • Change in nutritional status

    measured at week 0, 12 and 24

  • +4 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks

Behavioral: physical exerciseBehavioral: nutrition counselingDietary Supplement: whey protein supplement

Control group

NO INTERVENTION

Participants will receive standard care

Interventions

physical exerciseBEHAVIORAL

The standardized Training program will be performed twice a week in the Kantonsspital Winterthur and once a week in a home based setting

Intervention group
nutrition counselingBEHAVIORAL

At least 3 times, participants will receive nutrition counseling to improve energy- and protein intake

Intervention group
whey protein supplementDIETARY_SUPPLEMENT

On workout days study participants will consume twice a day 15 g of the supplement powder with approximately 150 ml water. On the remaining days participants consume the supplement once a day.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Advanced cancer patients not eligible for curative treatment: lung cancer, gastrointestinal cancer, breast cancer, prostate cancer, ovarian cancer, pleural mesothelioma, urothelium carcinoma, renal cell carcinoma
  • WHO performance status ≥ 2
  • Able to walk independently at least 100 meters
  • Estimated life expectancy of ≥ 6 month

You may not qualify if:

  • Patients currently using nutritional supplements with branched chain amino acids
  • Enteral or parenteral nutrition within 1 month
  • History of ileus within 1 month
  • Psychiatric disorder precluding understanding of information on trials related topics and giving informed consent
  • Milk protein allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

MeSH Terms

Conditions

Lung NeoplasmsBreast NeoplasmsProstatic NeoplasmsMesothelioma, MalignantCarcinoma, Transitional CellCarcinoma, Renal CellOvarian Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesMesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialPleural NeoplasmsCarcinomaAdenocarcinomaKidney NeoplasmsUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Miklos Pless, Prof.

    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

October 13, 2015

First Posted

October 23, 2015

Study Start

March 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

January 11, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)