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

This study has been completed.
Lance Armstrong Foundation
Information provided by:
Vanderbilt University Identifier:
First received: June 2, 2008
Last updated: July 25, 2011
Last verified: July 2011
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
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


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stage 3 or 4 HNC

Exclusion Criteria:

  • Previous Cancer
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Please refer to this study by its identifier: NCT00696553

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

Responsible Party: Heidi J. Silver, Vanderbilt University Identifier: NCT00696553     History of Changes
Other Study ID Numbers: 080219 
Study First Received: June 2, 2008
Last Updated: July 25, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site processed this record on May 23, 2016