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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tailored Nutrition Intervention
Nutrition plus Exercise
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stage 3 or 4 HNC

Exclusion Criteria:

  • Previous Cancer

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

B1

B2

Arm Description

Nutrition

Nutrition plus Exercise

Outcomes

Primary Outcome Measures

muscle mass loss

Secondary Outcome Measures

fatigue

Full Information

First Posted
June 2, 2008
Last Updated
July 25, 2011
Sponsor
Vanderbilt University
Collaborators
Lance Armstrong Foundation, Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT00696553
Brief Title
Nutrition and Resistance Training in Head and Neck Cancer
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vanderbilt University
Collaborators
Lance Armstrong Foundation, Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B1
Arm Type
Active Comparator
Arm Description
Nutrition
Arm Title
B2
Arm Type
Experimental
Arm Description
Nutrition plus Exercise
Intervention Type
Other
Intervention Name(s)
Tailored Nutrition Intervention
Intervention Description
Provision of individualized nutrition counseling and nutrition support using oral liquid nutrition supplements and/or liquid enteral supplements
Intervention Type
Behavioral
Intervention Name(s)
Nutrition plus Exercise
Intervention Description
Nutrition plus Exercise
Primary Outcome Measure Information:
Title
muscle mass loss
Time Frame
6 months
Secondary Outcome Measure Information:
Title
fatigue
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage 3 or 4 HNC Exclusion Criteria: Previous Cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi J Silver, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Nutrition and Resistance Training in Head and Neck Cancer

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