Clinical trial NCT03114202: Effects of Nutritional Counseling on Nutritional Status and Quality of Life of Head and Neck Cancer Patients
Official title: Effects of Intensive Nutritional Counseling on Nutritional Status and Quality of Life of Patients With Head and Neck Cancer Undergoing Radiation Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Neoplasms
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in weight
timeFrame: Baseline and 12 weeks
measure: Change in nutritional status
timeFrame: Baseline and 12 weeks
measure: Change in quality of life
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in patient generated subjective global assessment
timeFrame: Baseline and 12 weeks
measure: Energy and protein intake
timeFrame: Baseline and 12 weeks
measure: Fat free mass
timeFrame: Baseline and 12 weeks
measure: Occurrence of complications due to radiotherapy
timeFrame: 12 weeks
measure: Occurrence of unplanned hospitalization
timeFrame: 12 weeks
measure: Occurrence of interruption or delay in treatment.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Alfenas
country: Brazil
facility: Centro de Oncologia da Santa Casa Nossa Senhora do Perpétuo Socorro
state: Minas Gerais
city: Varginha
country: Brazil
facility: Fundação Hospitalar do Município de Varginha - Hospital Bom Pastor
state: Minas Gerais
Study officials:
affiliation: São Paulo University
name: Jose Eluf Neto
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Cancer de Barretos - Fundação PIO XII
name: Andre Carvalho
role: STUDY_CHAIR
affiliation: São Paulo University
name: Sheilla Faria
role: STUDY_CHAIR
References: