Back to resultsEffect of a Nutritional Supplement on H&N Cancer Patients
Primary Purpose
Head and Neck Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
behavior
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring cancer, nutrition
Eligibility Criteria
Inclusion Criteria: Head and neck cancer 1st.2nd wk Rx read &wrte eng Exclusion Criteria: receiving hospice impaired cognition
Sites / Locations
- Edward Hines, Jr. VA HospitalRecruiting
- Hines VA Hospital
Outcomes
Primary Outcome Measures
severity of mucositis
Secondary Outcome Measures
weight loss, quality of life
Full Information
NCT ID
NCT00296452
First Posted
February 23, 2006
Last Updated
February 23, 2006
Sponsor
Edward Hines Jr. VA Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00296452
Brief Title
Effect of a Nutritional Supplement on H&N Cancer Patients
Official Title
The Effect of an Enhanced Nutritional Supplement on Head and Neck Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Edward Hines Jr. VA Hospital
4. Oversight
5. Study Description
Brief Summary
To determine if using a nutritionally enhanced supplement will improve mucositis in head and neck cancer patients
Detailed Description
H&N cancer patients will be randomized to receive either a nutritionally enhanced product or standard treatment. The patients in both groups will receive nutritional counseling weekly by the RD. Anthropometric measures, available lab values, mucositis grade, and quality of life measures will be compared between groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
cancer, nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
behavior
Primary Outcome Measure Information:
Title
severity of mucositis
Secondary Outcome Measure Information:
Title
weight loss, quality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Head and neck cancer 1st.2nd wk Rx read &wrte eng
Exclusion Criteria:
receiving hospice impaired cognition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Foley, MS
Phone
708-202-2343
Ext
22343
Email
Sharon.Foley@med.va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Foley, MS
Organizational Affiliation
Hines VA Hosptial
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
carol bier-laning, MD
Organizational Affiliation
Hines VA Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Hines, Jr. VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Foley, MS
Phone
708-202-2343
Ext
22343
Email
Sharon.Foley@med.va.gov
Facility Name
Hines VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Individual Site Status
Suspended
12. IPD Sharing Statement
Learn more about this trial
Effect of a Nutritional Supplement on H&N Cancer Patients
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