Study Stopped
The study did not receive funding.
Impact of Nutrition and Swallowing Function of Head and Neck Cancer Patients During the Course of Treatment
1 other identifier
observational
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2010
CompletedFirst Posted
Study publicly available on registry
August 18, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedMay 23, 2016
May 1, 2016
1 year
August 17, 2010
May 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
nutrition status
evaluation of caloric intake
6 months
Secondary Outcomes (1)
swallowing function
6 months
Study Arms (4)
G-tube/swallowing intervention
patients will receive G-tube/nutritional and swallowing intervention. As per patient needs
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.
nutrition/swallowing counseling
Patients will have ad lib dietary intake with general nutrition and swallowing counseling.
Interventions
general nutrition and swalling information
Patient will have active swallowing intervention with an SLP
Patient will have active (daily) nutrition and swallowing intervention based on patients individual needs.
Eligibility Criteria
Advanced Head and Neck Cancer Patients
You may qualify if:
- ≥ 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.
You may not qualify if:
- unable to have safe swallow following surgery;
- allergy or intolerance to any enteral nutritional supplements in current use;
- renal insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alberta Hospital (Otolaryngology)
Edmonton, Alberta, T6G 2B7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine A Kubrak, PhD
University of Alberta
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 17, 2010
First Posted
August 18, 2010
Study Start
October 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
May 23, 2016
Record last verified: 2016-05