Nutrition and Physical Exercise Study | NCT01540968

Studies
Nutrition and Physical Exercise Study

NCT01540968

Sponsor

Kantonsspital Winterthur KSW

Status

Completed

Last Update Posted

Jun 26, 2015Estimated

Enrollment

58Actual

Phase

Not Applicable

Conditions

Gastrointestinal Cancer
Lung Cancer

Interventions

Nutrition & physical exercise

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KFS-2833-08-2011	Other Grant/Funding Number	Krebsforschung Schweiz / Krebsliga Schweiz

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Feb 23, 2012

First Submission Date that Met QC Criteria

Feb 28, 2012

First Posted Date

Feb 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2015

Last Update Posted Date

Jun 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the effect of a combined treatment of nutritional therapy and physical exercise in palliative cancer out-patients. The investigators hypothesize that this combined intervention consisting of an increased energy- and protein intake and physical exercise level improves quality of life (QoL), functional and clinical status.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nutrition & physical exercise	Experimental		Behavioral: Nutrition & physical exercise
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutrition & physical exercise	Behavioral	Patients will be randomly assigned to intensive individual nutritional counselling including oral nutritional supplements and a specifically designed exercise program combining strength and balance training.

Measure	Description	Time Frame
Quality of life		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed metastatic lung cancer or gastrointestinal cancer
WHO performance status 0, 1 or 2
Able to walk at least 100 meters independently without crutches or walking frame assessed by the treating physician on the basis of the patient's history and physical condition
Receiving palliative treatment

Exclusion Criteria:

Enteral and/or parenteral nutrition within 1 month previous to study participation
History of ileus within one month
Known brain metastases or symptomatic bone metastases
Psychiatric disorder precluding understanding of information on trial related topics and giving informed consent.
Any serious underlying medical condition which could impair the ability of the patient to participate in the trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter E. Ballmer, Prof. Dr.	Kantonsspital Winterthur KSW	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital Winterthur		Winterthur		8401	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009752	Nutritional Status
D015444	Exercise

Ancestor Terms

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D006304	Health Status

Browse Leaves

Not provided

Browse Branches

Not provided