NCT00696553

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3 head-and-neck-cancer

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 27, 2011

Status Verified

July 1, 2011

Enrollment Period

3.8 years

First QC Date

June 2, 2008

Last Update Submit

July 25, 2011

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • muscle mass loss

    6 months

Secondary Outcomes (1)

  • fatigue

    6 months

Study Arms (2)

B1

ACTIVE COMPARATOR

Nutrition

Other: Tailored Nutrition Intervention

B2

EXPERIMENTAL

Nutrition plus Exercise

Behavioral: Nutrition plus Exercise

Interventions

Tailored Nutrition InterventionOTHER

Provision of individualized nutrition counseling and nutrition support using oral liquid nutrition supplements and/or liquid enteral supplements

B1
Nutrition plus ExerciseBEHAVIORAL

Nutrition plus Exercise

B2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage 3 or 4 HNC

You may not qualify if:

  • Previous Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Nutritional StatusExercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Heidi J Silver, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2008

First Posted

June 12, 2008

Study Start

March 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 27, 2011

Record last verified: 2011-07

Locations

US(1)