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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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00375700
First received: September 11, 2006
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Head and Neck Cancer
 Dietary Supplement: Nutritional Supplement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • total energy and protein intake [ Time Frame: Study completion ]

Enrollment: 0
Study Start Date: November 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375700

Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Cathy Kubrak, PhD University of Alberta
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00375700     History of Changes
Other Study ID Numbers: HN-4-0029 / 23027
Study First Received: September 11, 2006
Last Updated: March 19, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
food
diet
oral supplement
head and neck cancer
radiation

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

ClinicalTrials.gov processed this record on May 22, 2013