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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Alberta.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT01184027
First received: August 17, 2010
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
  Purpose

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
Surgery
Nutrition
Swallowing
 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:

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • nutrition status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    evaluation of caloric intake


Secondary Outcome Measures:
  • swallowing function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    maintenance of swallowing function


Estimated Enrollment: 24
Study Start Date: October 2010
Estimated Study Completion Date: October 2011
Estimated 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

  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

Advanced Head and Neck Cancer Patients

Criteria

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184027

Contacts
Contact: Catherine A Kubrak, PhD 780-407-6477 ckubrak@ualberta.ca

Locations
Canada, Alberta
University of Alberta Hospital (Otolaryngology) Active, not recruiting
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Catherine A Kubrak, PhD University of Alberta
  More Information

No publications provided

Responsible Party: Catherine Kubrak, University of Alberta, Department of Surgery (Otolaryngology)
ClinicalTrials.gov Identifier: NCT01184027     History of Changes
Other Study ID Numbers: HN 11226
Study First Received: August 17, 2010
Last Updated: March 1, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
head and neck cancer
surgery
nutrition

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

ClinicalTrials.gov processed this record on May 16, 2013