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NCT00696553 Clinical Trial

Nutrition and Resistance Training in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

— ELAF  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00696553
Other study ID # 080219
Secondary ID
Status Completed
Phase Phase 3
First received June 2, 2008
Last updated July 25, 2011
Start date March 2006
Est. completion date January 2010

Study information
Verified date July 2011
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Stage 3 or 4 HNC

Exclusion Criteria:

- Previous Cancer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Other:
• Tailored Nutrition Intervention
Provision of individualized nutrition counseling and nutrition support using oral liquid nutrition supplements and/or liquid enteral supplements
Behavioral:
• Nutrition plus Exercise
Nutrition plus Exercise

Locations
Country Name City State
United States Vanderbilt University Nashville Tennessee

Sponsors (3)
Lead Sponsor Collaborator
Vanderbilt University Lance Armstrong Foundation, Nestlé

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary muscle mass loss 6 months No
Secondary fatigue 6 months No
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