Nutrition and Physical Exercise Study

NCT ID: NCT01540968

Last Updated: 2015-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Gastrointestinal Cancer Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nutrition & physical exercise

Group Type EXPERIMENTAL

Nutrition & physical exercise

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutrition & physical exercise

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Winterthur KSW

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter E. Ballmer, Prof. Dr.

Role: STUDY_CHAIR

Kantonsspital Winterthur KSW

Locations

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Kantonsspital Winterthur

Winterthur, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KFS-2833-08-2011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KEK-ZH-Nr. 2011-0447

Identifier Type: -

Identifier Source: org_study_id

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