Nutrition and Resistance Training in Head and Neck Cancer - Full Text View

Sponsors and Collaborators:	Vanderbilt University Lance Armstrong Foundation Nestle Clinical Nutrition
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00696553

Purpose

To test the effects of nutrition versus nutrition with resistance exercise on muscle mass loss, fatigue and outcomes of concurrent chemo radiation.

Condition	Intervention	Phase
Head and Neck Cancer	Other: Tailored Nutrition Intervention Behavioral: Nutrition plus Exercise	Phase III

MedlinePlus related topics: Cancer Exercise and Physical Fitness Head and Neck Cancer Nutritional Support

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Trial of Specialized Nutrition Therapy (SNT) Versus SNT Plus Resistance Training (RT) in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation Therapy (CCR)

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	60
Study Start Date:	March 2006
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B1: Active Comparator Nutrition	Other: Tailored Nutrition Intervention Provision of individualized nutrition counseling and nutrition support using oral liquid nutrition supplements and/or liquid enteral supplements
B2: Experimental Nutrition plus Exercise	Behavioral: Nutrition plus Exercise Nutrition plus Exercise

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696553

Locations

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

Lance Armstrong Foundation

Nestle Clinical Nutrition

Investigators

Principal Investigator:

Heidi J Silver, PhD

Vanderbilt University

More Information

Responsible Party:	Vanderbilt University ( Heidi J. Silver )
Study ID Numbers:	080219
Study First Received:	June 2, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00696553
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Head and Neck Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009