CompletedNCT00696553ELAFUpdated Jul 27, 2011

Nutrition and Resistance Training in Head and Neck Cancer

A Phase 3 interventional study of Tailored Nutrition Intervention and Nutrition plus Exercise in Head and Neck Cancer, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2011-07-27.

Sponsored by Vanderbilt University · Phase 3, Interventional, and Supportive care

Phase: Phase 3
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 21 Years and older
Sex: All

Study summary

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

Conditions studied

Head and Neck Cancer

Browse trials for

Head and Neck Neoplasms 2,344

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 60 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Stage 3 or 4 HNC

Exclusion criteria

Exclusion Criteria:

Previous Cancer

Study design

Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 60 participants (estimated)

Study arms

Active comparator
B1
Nutrition
Other: Tailored Nutrition Intervention
Experimental
B2
Nutrition plus Exercise
Behavioral: Nutrition plus Exercise

Interventions

OtherTailored Nutrition Intervention
Provision of individualized nutrition counseling and nutrition support using oral liquid nutrition supplements and/or liquid enteral supplements
BehavioralNutrition plus Exercise
Nutrition plus Exercise

What researchers measure

Primary outcomes

muscle mass loss
Time frame: 6 months

Secondary outcomes

fatigue
Time frame: 6 months

Study locations

1 site

Vanderbilt University
Nashville, Tennessee 37232, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00696553
Lead sponsor: Vanderbilt University
Collaborators: Lance Armstrong Foundation, Société des Produits Nestlé (SPN)
First posted: Jun 12, 2008
Start date: Mar 2006
Primary completion: Jan 2010
Completion: Jan 2010
Last update: Jul 27, 2011

Study contacts

Heidi J Silver, PhD

principal investigator · Vanderbilt University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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