Effect of a Nutritional Supplement on H&N Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Edward Hines Jr. VA Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Edward Hines Jr. VA Hospital
ClinicalTrials.gov Identifier:
NCT00296452
First received: February 23, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  Purpose

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


Condition Intervention
Head and Neck Cancer
Behavioral: behavior

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of an Enhanced Nutritional Supplement on Head and Neck Cancer Patients

Resource links provided by NLM:


Further study details as provided by Edward Hines Jr. VA Hospital:

Primary Outcome Measures:
  • severity of mucositis

Secondary Outcome Measures:
  • weight loss, quality of life

Estimated Enrollment: 40
Study Start Date: February 2006
Estimated Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • receiving hospice impaired cognition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296452

Contacts
Contact: Sharon Foley, MS 708-202-2343 ext 22343 Sharon.Foley@med.va.gov

Locations
United States, Illinois
Hines VA Hospital Suspended
Hines, Illinois, United States, 60141
Edward Hines, Jr. VA Hospital Recruiting
Hines, Illinois, United States, 60141
Contact: Sharon Foley, MS    708-202-2343 ext 22343    Sharon.Foley@med.va.gov   
Sponsors and Collaborators
Edward Hines Jr. VA Hospital
Investigators
Principal Investigator: Sharon Foley, MS Hines VA Hosptial
Principal Investigator: carol bier-laning, MD Hines VA Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00296452     History of Changes
Other Study ID Numbers: 0033
Study First Received: February 23, 2006
Last Updated: February 23, 2006
Health Authority: United States: Federal Government

Keywords provided by Edward Hines Jr. VA Hospital:
cancer
nutrition

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014