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Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00375180
First received: September 11, 2006
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.


Condition
Head and Neck Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients Prior to, on Completion of and Six Weeks After Oncology Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Enrollment: 100
Study Start Date: November 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Head and neck cancer patients often have difficulty meeting their nutritional needs while undergoing radiation therapy (RT) and/or chemotherapy (RTchemo). Tumor locations and side effects of RT or RTchemo, including dry mouth, mouth sores, difficulty chewing and swallowing, changes in taste and smell, and loss of appetite, lead to poor food intake and weight loss. The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx, and thyroid

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 histological types of cancer
  • All tumour stages according to American Joint Committee for Cancer (AJCC) Staging
  • All forms of RT including standard or investigational and/or concurrent standard or investigational chemotherapy for head and neck cancers
  • Alert and mentally competent
  • English speaking

Exclusion Criteria:

  • Unwilling to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375180

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Vickie Baracos, MD Alberta Health Services
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00375180     History of Changes
Other Study ID Numbers: HN-4-0030 / 23028
Study First Received: September 11, 2006
Last Updated: March 19, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
food
diet
mucositis
xerostomia
dysphagia
 taste
smell
head and neck
radiation
chemotherapy

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

ClinicalTrials.gov processed this record on May 19, 2013