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

This study has been completed.
Sponsor:
Collaborators:
Lance Armstrong Foundation
Nestlé
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00696553
First received: June 2, 2008
Last updated: July 25, 2011
Last verified: July 2011
  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
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
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

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

Inclusion Criteria:

  • Stage 3 or 4 HNC

Exclusion Criteria:

  • Previous Cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Nestlé
Investigators
Principal Investigator: Heidi J Silver, PhD Vanderbilt University
  More Information

No publications provided

Responsible Party: Heidi J. Silver, Vanderbilt University
ClinicalTrials.gov 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
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2014