Expired Study
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Nashville, Tennessee 37232


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


Inclusion Criteria: - Stage 3 or 4 HNC Exclusion Criteria: - Previous Cancer

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:


Brief Title:

Nutrition and Resistance Training in Head and Neck Cancer

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)

Overall Status:


Study Phase:

Phase 3



Minimum Age:

21 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Heidi J Silver, PhD
Principal Investigator
Vanderbilt University

Study Dates

Start Date:March 2006
Completion Date:January 2010
Completion Type:Actual
Primary Completion Date:January 2010
Primary Completion Type:Actual
Verification Date:July 2011
Last Changed Date:July 25, 2011
First Received Date:June 2, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Time Frame:6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:muscle mass loss
Time Frame:6 months
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Tailored Nutrition Intervention
Description:Provision of individualized nutrition counseling and nutrition support using oral liquid nutrition supplements and/or liquid enteral supplements
Arm Name:B1
Intervention Type:Behavioral
Name:Nutrition plus Exercise
Description:Nutrition plus Exercise
Arm Name:B2

Study Arms

Study Arm Type:Experimental
Arm Name:B2
Description:Nutrition plus Exercise
Study Arm Type:Active Comparator
Arm Name:B1

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Lance Armstrong Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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