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

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ClinicalTrials.gov Identifier: NCT00696553
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : July 27, 2011
Sponsor:
Collaborators:
Lance Armstrong Foundation
Nestlé
Information provided by:
Vanderbilt University

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

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Other: Tailored Nutrition Intervention Behavioral: Nutrition plus Exercise Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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)
Study Start Date : March 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. fatigue [ Time Frame: 6 months ]


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

Inclusion Criteria:

  • Stage 3 or 4 HNC

Exclusion Criteria:

  • Previous Cancer

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

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

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