Effect of an Oral Supplement on the Total Energy and Protein Intake of Head and Neck Cancer Patients in the Last 2 Weeks of Radiation Therapy

February 24, 2016 updated by: AHS Cancer Control Alberta

Efficacy of an Oral Nutrition Supplement on the Total Caloric and Protein Intake of Head and Neck Cancer Patients During the Last 2 Weeks of Radiation Therapy

In this study, an oral nutrition supplement has been developed that take into consideration: the nutritional requirements, treatment side-effects and taste preferences of head and neck cancer patients; the acceptance of a supplement when experiencing radiation therapy side-effects; and the taste preferences of head and neck cancer patients which may affect the supplement intake. We hope to increase dietary intake during the last 2 weeks of radiation therapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx and thyroid.
  • all histologic types of cancer
  • all tumour stages according to American Joint Committee for Cancer (AJCC) Staging
  • all forms of RT including standard or investigational for head and neck cancers
  • alert and mentally competent
  • English speaking

Exclusion Criteria:

  • an allergy or intolerance to any of the substances used in the nutrition supplement
  • Type I or II diabetes mellitus
  • renal insufficiency
  • unable to swallow
  • additional criteria of all forms of chemotherapy standard or investigational or combination of radiation/chemotherapy standard or investigational for head and neck cancers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
total energy and protein intake
Time Frame: Study completion
Study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

Investigators

  • Principal Investigator: Cathy Kubrak, PhD, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 11, 2006

First Submitted That Met QC Criteria

September 11, 2006

First Posted (Estimate)

September 13, 2006

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN-4-0029 / 23027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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