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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

Primary Purpose

Head and Neck Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional Supplement
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring food, diet, oral supplement, head and neck cancer, radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    total energy and protein intake

    Secondary Outcome Measures

    Full Information

    First Posted
    September 11, 2006
    Last Updated
    February 24, 2016
    Sponsor
    AHS Cancer Control Alberta
    Collaborators
    Cross Cancer Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00375700
    Brief Title
    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
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    November 2006 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    January 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AHS Cancer Control Alberta
    Collaborators
    Cross Cancer Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer
    Keywords
    food, diet, oral supplement, head and neck cancer, radiation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Nutritional Supplement
    Primary Outcome Measure Information:
    Title
    total energy and protein intake
    Time Frame
    Study completion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cathy Kubrak, PhD
    Organizational Affiliation
    University of Alberta
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    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

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