Nutrition and Physical Exercise Study

Lung Cancer Clinical Trial

Official title:

Influence of a Combined Intervention by Nutritional Support and Physical Exercise on Quality of Life in Cancer Out-patients Treated in Palliative Intention.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540968
• Other study ID #: KEK-ZH-Nr. 2011-0447
• Secondary ID: KFS-2833-08-2011
• Status: Completed
• Phase: N/A
• First received: February 23, 2012
• Last updated: June 25, 2015
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: Kantonsspital Winterthur KSW
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Lung Cancer

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Winterthur	Winterthur

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		3 months	No