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Effect of a Nutritional Supplement on H&N Cancer Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2006 by Edward Hines Jr. VA Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00296452
First Posted: February 27, 2006
Last Update Posted: February 27, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Edward Hines Jr. VA Hospital
  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
Intervention Model: Factorial Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296452


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

Locations
United States, Illinois
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   
Hines VA Hospital Suspended
Hines, Illinois, United States, 60141
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

ClinicalTrials.gov Identifier: NCT00296452     History of Changes
Other Study ID Numbers: 0033
First Submitted: February 23, 2006
First Posted: February 27, 2006
Last Update Posted: February 27, 2006
Last Verified: February 2006

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

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