Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Nashville, Tennessee 37232


Purpose:

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


Criteria:

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


Study is Available At:


Original ID:

080219


NCT ID:

NCT00696553


Secondary ID:


Study Acronym:

ELAF


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:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

N/A


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:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Anticipated


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
Measure:fatigue
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
Description:Nutrition

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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.