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Sponsors and Collaborators: |
Vanderbilt University Lance Armstrong Foundation Nestle Clinical Nutrition |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00696553 |
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 |
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Head and Neck Cancer |
Other: Tailored Nutrition Intervention Behavioral: Nutrition plus Exercise |
Phase III |
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) |
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 |
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B1: Active Comparator
Nutrition
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Other: Tailored Nutrition Intervention
Provision of individualized nutrition counseling and nutrition support using oral liquid nutrition supplements and/or liquid enteral supplements
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B2: Experimental
Nutrition plus Exercise
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Behavioral: Nutrition plus Exercise
Nutrition plus Exercise
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Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Heidi J Silver, PhD | Vanderbilt University |
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 |
Head and Neck Neoplasms |
Neoplasms Neoplasms by Site |