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Nutrition and Resistance Training in Head and Neck Cancer (ELAF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00696553
First Posted: June 12, 2008
Last Update Posted: July 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Lance Armstrong Foundation
Nestlé
Information provided by:
Vanderbilt University
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
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)

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • muscle mass loss [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • fatigue [ Time Frame: 6 months ]

Estimated Enrollment: 60
Study Start Date: March 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B1
Nutrition
Other: Tailored Nutrition Intervention
Provision of individualized nutrition counseling and nutrition support using oral liquid nutrition supplements and/or liquid enteral supplements
Experimental: B2
Nutrition plus Exercise
Behavioral: Nutrition plus Exercise
Nutrition plus Exercise

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage 3 or 4 HNC

Exclusion Criteria:

  • Previous Cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696553


Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Lance Armstrong Foundation
Nestlé
Investigators
Principal Investigator: Heidi J Silver, PhD Vanderbilt University
  More Information

Responsible Party: Heidi J. Silver, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00696553     History of Changes
Other Study ID Numbers: 080219
First Submitted: June 2, 2008
First Posted: June 12, 2008
Last Update Posted: July 27, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms