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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
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.
Nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist.
Centro de Oncologia da Santa Casa Nossa Senhora do Perpétuo Socorro
Alfenas, Minas Gerais, Brazil
RECRUITINGFundação Hospitalar do Município de Varginha - Hospital Bom Pastor
Varginha, Minas Gerais, Brazil
RECRUITINGChange in weight
Defined as mean weight change
Time frame: Baseline and 12 weeks
Change in nutritional status
Defined as mean body mass index change
Time frame: 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).
Time frame: Baseline and 12 weeks
Change in patient generated subjective global assessment
Self reported nutritional assessment by the Scored Patient-Generated Subjective Global Assessment (PG-SGA)
Time frame: Baseline and 12 weeks
Energy and protein intake
Mean changes in energy and protein intake, assessed by the 24 hour recording
Time frame: Baseline and 12 weeks
Fat free mass
Mean changes in fat free mass, assessed by foot-to-foot bioimpedance
Time frame: Baseline and 12 weeks
Occurrence of complications due to radiotherapy
Number of patients with complications due to radiotherapy, assessed from medical record
Time frame: 12 weeks
Occurrence of unplanned hospitalization
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Number of patients with unplanned hospitalization, assessed from medical record
Time frame: 12 weeks
Occurrence of interruption or delay in treatment.
Number of patients with interruption or delay in treatment, assessed from medical records
Time frame: 12 weeks