Head and Neck Neoplasms
Conditions
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).
Interventions
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.
OTHERStandard care
Nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | Baseline and 12 weeks | Defined as mean weight change |
| Change in nutritional status | Baseline and 12 weeks | Defined as mean body mass index change |
| Change in quality of life | Baseline 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of complications due to radiotherapy | 12 weeks | Number of patients with complications due to radiotherapy, assessed from medical record |
| Change in patient generated subjective global assessment | Baseline and 12 weeks | Self reported nutritional assessment by the Scored Patient-Generated Subjective Global Assessment (PG-SGA) |
| Occurrence of interruption or delay in treatment. | 12 weeks | Number of patients with interruption or delay in treatment, assessed from medical records |
| Occurrence of unplanned hospitalization | 12 weeks | Number of patients with unplanned hospitalization, assessed from medical record |
| Energy and protein intake | Baseline and 12 weeks | Mean changes in energy and protein intake, assessed by the 24 hour recording |
| Fat free mass | Baseline and 12 weeks | Mean changes in fat free mass, assessed by foot-to-foot bioimpedance |
Countries
Brazil
Contacts
Primary ContactJose Eluf Neto
Backup ContactSheilla Faria
Outcome results
None listed