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

Not Applicable
Conditions
Head and Neck Neoplasms
Interventions
Other: intensive nutritional counseling
Other: Standard care
Registration Number
NCT03114202
Lead Sponsor
University of Sao Paulo General Hospital
Brief Summary

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

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).

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
90
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).
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Exclusion Criteria
  • Patients using parenteral nutrition; without cognitive ability to understand the concepts of the questionnaires; in palliative radiotherapy.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention groupintensive nutritional counselingIntensive nutritional counseling: once they are admitted to the study and once a week during radiotherapy
Control groupStandard careStandard care: when there is demand, usually 1 to 2 times during radiotherapy
Primary Outcome Measures
NameTimeMethod
Change in quality of lifeBaseline and 12 weeks

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).

Change in weightBaseline and 12 weeks

Defined as mean weight change

Change in nutritional statusBaseline and 12 weeks

Defined as mean body mass index change

Secondary Outcome Measures
NameTimeMethod
Energy and protein intakeBaseline and 12 weeks

Mean changes in energy and protein intake, assessed by the 24 hour recording

Occurrence of complications due to radiotherapy12 weeks

Number of patients with complications due to radiotherapy, assessed from medical record

Fat free massBaseline and 12 weeks

Mean changes in fat free mass, assessed by foot-to-foot bioimpedance

Change in patient generated subjective global assessmentBaseline and 12 weeks

Self reported nutritional assessment by the Scored Patient-Generated Subjective Global Assessment (PG-SGA)

Occurrence of unplanned hospitalization12 weeks

Number of patients with unplanned hospitalization, assessed from medical record

Occurrence of interruption or delay in treatment.12 weeks

Number of patients with interruption or delay in treatment, assessed from medical records

Trial Locations

Locations (2)

Centro de Oncologia da Santa Casa Nossa Senhora do Perpétuo Socorro

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Alfenas, Minas Gerais, Brazil

Fundação Hospitalar do Município de Varginha - Hospital Bom Pastor

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Varginha, Minas Gerais, Brazil

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