NCT00296452

Brief Summary

To determine if using a nutritionally enhanced supplement will improve mucositis in head and neck cancer patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

2 active sites

Status
unknown

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

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
Last Updated

February 27, 2006

Status Verified

February 1, 2006

First QC Date

February 23, 2006

Last Update Submit

February 23, 2006

Conditions

Head and Neck Cancer

Keywords

cancernutrition

Outcome Measures

Primary Outcomes (1)

  • severity of mucositis

Secondary Outcomes (1)

  • weight loss, quality of life

Interventions

behaviorBEHAVIORAL

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Head and neck cancer 1st.2nd wk Rx read \&wrte eng

You may not qualify if:

  • receiving hospice impaired cognition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141, United States

RECRUITING

Hines VA Hospital

Hines, Illinois, 60141, United States

SUSPENDED

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Officials

  • Sharon Foley, MS

    Hines VA Hosptial

    PRINCIPAL INVESTIGATOR

  • carol bier-laning, MD

    Hines VA Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Foley, MS

CONTACT

708-202-2343Sharon.Foley@med.va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED

Study Record Dates

First Submitted

February 23, 2006

First Posted

February 27, 2006

Study Start

February 1, 2006

Study Completion

February 1, 2006

Last Updated

February 27, 2006

Record last verified: 2006-02

Locations

US(2)