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Impact of Nutrition and Swallowing Function of Head and Neck Cancer Patients During the Course of Treatment

This study has been withdrawn prior to enrollment.
(The study did not receive funding.)
Information provided by (Responsible Party):
Catherine Kubrak, University of Alberta Identifier:
First received: August 17, 2010
Last updated: May 19, 2016
Last verified: May 2016
Weight loss resulting from poor food intake is common in head and neck cancer patients. Currently, feeding tubes are placed before starting treatment to provide nutrition and prevent weight loss. However, studies have not always shown that feeding tubes prevent weight loss. Also, limiting food intake by mouth may lead to swallowing problems. The aim of this study is to compare the effect of diet and swallowing therapy with feeding tube placement. In this study, your weight, food intake, swallowing ability, and side-effects of treatment will be monitored before, during, and 3 and 6 months after treatment to see if there is any difference between the therapy groups. The investigators hope that with the addition of diet and swallowing therapy during treatment that we can improve food intake and swallowing ability while still maintaining weight.

Condition Intervention
Head and Neck Cancer
Behavioral: nutrition /swallowing counseling
Behavioral: G-tube/swallowing intervention
Behavioral: nutrition /swallowing intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Nutrition and Swallowing Function in a Randomized Controlled Trial of Head and Neck Cancer Patients During the Course of Treatment

Resource links provided by NLM:

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • nutrition status [ Time Frame: 6 months ]
    evaluation of caloric intake

Secondary Outcome Measures:
  • swallowing function [ Time Frame: 6 months ]
    maintenance of swallowing function

Enrollment: 0
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
G-tube/swallowing intervention
patients will receive G-tube/nutritional and swallowing intervention. As per patient needs
Behavioral: G-tube/swallowing intervention
Patient will have active swallowing intervention with an SLP
Other Name: Group 1
G-tube/swallowing counseling
G-tube/ad lib dietary and swallowing counseling. Current standard of care.
nutrition/swallowing intervention
Patients will receive active nutrition and swallowing intervention based on patients caloric and swallowing needs.
Behavioral: nutrition /swallowing intervention
Patient will have active (daily) nutrition and swallowing intervention based on patients individual needs.
Other Name: Group 3
nutrition/swallowing counseling
Patients will have ad lib dietary intake with general nutrition and swallowing counseling.
Behavioral: nutrition /swallowing counseling
general nutrition and swalling information
Other Name: Group 4

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Advanced Head and Neck Cancer Patients
  • Inclusion criteria are:

    • ≥ 18 years of age;
    • diagnosed with HN cancer to sites of the oral cavity, pharynx, and larynx;
    • all histologic types of cancer;
    • advanced tumour stages;
    • all forms of RT including standard or investigational for HNC;
    • all forms of CT including standard or investigational for HNC;
    • alert and mentally competent;
    • English-speaking.

Exclusion criteria are:

  • unable to have safe swallow following surgery;
  • allergy or intolerance to any enteral nutritional supplements in current use;
  • renal insufficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01184027

Canada, Alberta
University of Alberta Hospital (Otolaryngology)
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Principal Investigator: Catherine A Kubrak, PhD University of Alberta
  More Information

Responsible Party: Catherine Kubrak, Principal Investigator, University of Alberta Identifier: NCT01184027     History of Changes
Other Study ID Numbers: HN 11226
Study First Received: August 17, 2010
Last Updated: May 19, 2016

Keywords provided by University of Alberta:
head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms processed this record on May 22, 2017