Impact of Nutrition and Swallowing Function of Head and Neck Cancer Patients During the Course of Treatment
Impact of Nutrition and Swallowing Function of Head and Neck Cancer Patients During the Course of Treatment
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.
Background: Multimodal treatment for advanced head and neck cancer (HNC) is associated with
 acute toxicities including mucositis, xerostomia, and dysphagia and a high prevalence of
 weight loss, requiring nutritional intervention. Currently, there is ongoing debate about the
 best way to provide nutrition support while undergoing chemoradiation (CRT) therapy after
 surgery for advanced head and neck cancer (HNC). Randomized controlled trials comparing the
 nutritional benefits of feeding tubes over dietary counseling and/or supplementation have not
 conclusively demonstrated a reduction in weight loss, unplanned hospitalizations, treatment
 toxicities, or tumour control. Additionally, the relative benefits of feeding tubes are
 controversial. Studies evaluating the efficacy of feeding tubes report that patients with
 feeding tubes have increased risk of aspiration, feeding tube dependence, a small but finite
 risk of tumour seeding, but more importantly long term functional swallowing impairment.
 However, emerging data are reporting that swallowing exercise programs that are designed to
 strengthen musculature throughout the course of treatment may lead to improved return of
 functional swallowing. Thus, preservation of functional swallowing may potentially improve
 return to oral nutrition.

 Purpose: Our purpose of this study is to compare the efficacy of nutritional and swallowing
 intervention with/out a percutaneous endoscopic gastrostomy (PEG) tube to that of ad lib
 nutrition and swallowing counseling with/out a PEG tube in advanced HNC patients. Weight,
 caloric intake, instrumental swallowing function, xerostomia, mucositis, pain, unplanned
 treatment interruptions, unplanned hospital admissions, complications, duration of feeding
 tube, tumour control, performance status, and quality of life (QOL) will be assessed before,
 during, 3 and 6 months after CRT therapy to determine if there is any differences between the
 intervention groups.

 Study Design: A randomized controlled longitudinal design during the entire course of
 treatment including surgery and CRT therapy will be conducted to investigate the efficacy of
 nutritional and swallowing interventions in HNC patients at baseline, after each course of
 consecutive course treatment and 3 and 6 month follow-up. Patients demonstrating a safe
 functional swallow following surgery will be randomly assigned to one of four groups: Group 1
 - patients will receive PEG tube/in-depth nutrition and swallowing intervention; Group 2 -
 patients will receive PEG tube/ad lib nutrition and swallowing counseling; Group 3 - patients
 will receive in-depth nutrition and swallowing intervention; or Group 4 - patients will
 receive ad lib nutrition/Kaofeed tube nutrition and swallowing counseling.

 Study Sample: Patients with diagnosis of HNC to the oral cavity, pharynx, and larynx
 undergoing surgery and CRT therapy at the University of Alberta Hospital (UAH) and Cross
 Cancer Institute (CCI) will be eligible for participation in the study.

 Inclusion criteria are: ≥ 18 years of age; diagnosed with HNC to sites of the oral cavity,
 oropharynx, and larynx; all histologic types of cancer; advanced tumour stages; all forms of
 radiation therapy (RT) including standard or investigational for HNC; all forms of
 chemotherapy (CT) including standard or investigational for HNC; alert and mentally
 competent; English-speaking. Exclusion criteria are: unable to have safe swallow following
 surgical intervention; allergy or intolerance to any enteral nutritional supplements in
 current use; renal insufficiency. There are approximately 3-4 HNC patients scheduled for
 surgery, and CRT therapy per week at UAH/CCI. With a significance level of 0.01 between
 groups and a power of 0.85 (an effect size of 0.9) a minimum sample size of 41 patients is
 required for this study. As a pilot study with 20 degrees of freedom, an adequate and
 reasonable sample size would require 24 patients to be recruited to participate.

 Data Collection: Patients will be informed of the study and consent obtained. Demographic and
 clinical data will be collected at the time of recruitment. Patient's height and weight will
 be recorded. Patients will be asked to complete the Patient Generated Subjective Global
 Assessment, Head and Neck Symptom Checklist, Edmonton Symptom Assessment Score and University
 of Washington Quality of Life Revised Questionnaire. Patients will be given instructions on
 how to complete the 24h dietary recall, will have assessments for mucositis and xerostomia
 and an appointment for modified barium swallow. After surgery, patient's who have a verified
 safe swallow by a speech-language pathologist (SLP) and MBS will be randomized into 1 of 4
 groups. Patient randomized to Group 1 or 2 will have percutaneous gastrostomy (PEG) tubes
 inserted as per gastroenterology PEG tube insertion protocol. Patients randomized to Group 1
 or 3 will have additional nutrition and swallowing intervention. Patients randomized to Group
 3 or 4 who have symptoms that prevent them from swallowing or have a >5% weight loss during
 treatment will be offered a Kaofeed tube for nutrition supplementation. Nutritional
 intervention as outlined in studies by Ravasco et al. (2005) and Goncalves Dias et al (2005)
 will include individualized nutrition orientation to therapeutic diet that will aid the
 patient in achieving a caloric and protein intake which promotes approximately 40
 kcal/kg/day. The nurse practitioner together with the patient will meet on a daily basis to
 review their therapeutic diet and resolve issues of symptom management that prevent dietary
 intake. Swallowing intervention will include evaluation of functional swallowing by a SLP.
 The SLP together with the patient will meet on a daily basis to review functional swallowing
 and will teach/aid the patient to adjust their swallowing to meet their changing safe
 swallowing needs. All parameters and study measurement are outlined in Table 1.

 Data Analysis: Descriptive statistics will be used to generate a profile of the nutrition
 status, caloric intake, nutrition impact symptoms, swallowing function, quality of life,
 unplanned treatment interruptions, unplanned hospital admissions, and complications of HNC
 patients at baseline, after each course of consecutive course treatment and 3 month
 follow-up. Changes, as well as differences in nutrition status, caloric intake, nutrition
 impact symptoms, quality of life and swallowing function before and after each course of
 treatment, and 3 month follow-up will be examined using t-tests and analysis of variance
 (ANOVA).

 Significance of the Study: The high prevalence and negative consequences of weight loss,
 primarily stemming from dysphagia in advanced HNC patients using the current multimodal
 treatment regime supports the need to determine the most effective nutritional management of
 this patient group. Additionally, this pilot study may establish the foundation for future
 protocols and guidelines for nutritional care of HNC 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