Effects of Nutritional Counseling on Nutritional Status and Quality of Life of Head and Neck Cancer Patients

Study Overview
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Brief Summary
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This study investigates the effects of nutritional counseling versus standard nutritional care on nutritional status and quality of life in patients with head and neck cancer submitted to radiotherapy.Half participants will receive intensive nutritional counseling while the other half will receive standard care.

Detailed Description
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Considering that head and neck cancer patients usually present reduced food intake with consequent involuntary weight loss and significant worsening of quality of life, this study investigates the effects of nutritional counseling versus standard nutritional care on nutritional status and quality of life in patients with head and neck cancer submitted to radiotherapy. Half participants (45) will receive intensive nutritional counseling, that is, once they are admitted to the study and once a week during radiotherapy, following the protocol of nutritional care to cancer patients in radiotherapy proposed by the American Dietetic Association (ADA). The other half (45) will receive standard care, that is, nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist (when there is a demand, usually 1 to 2 times during oncologic treatment).

Official Title
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Effects of Intensive Nutritional Counseling on Nutritional Status and Quality of Life of Patients With Head and Neck Cancer Undergoing Radiation Therapy

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Other: intensive nutritional counseling
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with head and neck cancer (oral cavity, oropharynx, hypopharynx and larynx); both sexes; aged 18 years and over, submitted to radiotherapy after chemotherapy or radiotherapy as a first-choice treatment or as adjuvant treatment (post-surgical). Exclusion Criteria: Patients using parenteral nutrition; without cognitive ability to understand the concepts of the questionnaires; in palliative radiotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intensive nutritional counseling: once they are admitted to the study and once a week during radiotherapy | Other: intensive nutritional counseling<br>* Individualised nutrition intervention in the form of regular and intensive nutrition counselling by a dietitian, following a predetermined standard nutrition protocol, the Medical Nutrition Therapy (Cancer/Radiation Oncology) protocol of the American Dietetic Association (ADA) every week during radiotherapy. Individually tailored sample meal plans, recipe suggestions and hints to minimise the side effects of the tumour and therapy will be provided.<br>|
| Other: Control group<br>Standard care: when there is demand, usually 1 to 2 times during radiotherapy | Other: Standard care<br>* Nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Defined as mean weight change | Baseline and 12 weeks | 
| Change in nutritional status | Defined as mean body mass index change | Baseline and 12 weeks | 
| Change in quality of life | Self reported quality of life assessed using two questionnaires - Functional Assessment of Cancer Therapy - Head and Neck (FACT-H & N) and European Organization for Research and Treatment of Cancer - Quality of life questionnaire - Head and Neck (EORTC-QLQ-H & N35). | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient generated subjective global assessment | Self reported nutritional assessment by the Scored Patient-Generated Subjective Global Assessment (PG-SGA) | Baseline and 12 weeks | 
| Energy and protein intake | Mean changes in energy and protein intake, assessed by the 24 hour recording | Baseline and 12 weeks | 
| Fat free mass | Mean changes in fat free mass, assessed by foot-to-foot bioimpedance | Baseline and 12 weeks | 
| Occurrence of complications due to radiotherapy | Number of patients with complications due to radiotherapy, assessed from medical record | 12 weeks | 
| Occurrence of unplanned hospitalization | Number of patients with unplanned hospitalization, assessed from medical record | 12 weeks | 
| Occurrence of interruption or delay in treatment. | Number of patients with interruption or delay in treatment, assessed from medical records | 12 weeks |