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NCT00296452 Clinical Trial

Effect of a Nutritional Supplement on H&N Cancer Patients

Head and Neck Cancer Clinical Trial

Official title:
The Effect of an Enhanced Nutritional Supplement on Head and Neck Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00296452
Other study ID # 0033
Secondary ID
Status Recruiting
Phase N/A
First received February 23, 2006
Last updated February 23, 2006
Start date February 2006
Est. completion date February 2006

Study information
Verified date February 2006
Source Edward Hines Jr. VA Hospital
Contact Sharon Foley, MS
Phone 708-202-2343
Email Sharon.Foley@med.va.gov
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- receiving hospice impaired cognition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• behavior

Locations
Country Name City State
United States Edward Hines, Jr. VA Hospital Hines Illinois
United States Hines VA Hospital Hines Illinois

Sponsors (1)
Lead Sponsor Collaborator
Edward Hines Jr. VA Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary severity of mucositis
Secondary weight loss, quality of life
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