Effects of Nutritional Counseling on Nutritional Status and Quality of Life of Head and Neck Cancer Patients
- Conditions
- Head and Neck Neoplasms
- Interventions
- Other: intensive nutritional counselingOther: 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
- 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).
- Patients using parenteral nutrition; without cognitive ability to understand the concepts of the questionnaires; in palliative radiotherapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group intensive nutritional counseling Intensive nutritional counseling: once they are admitted to the study and once a week during radiotherapy Control group Standard care Standard care: when there is demand, usually 1 to 2 times during radiotherapy
- Primary Outcome Measures
Name Time Method 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).
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
- Secondary Outcome Measures
Name Time Method Energy and protein intake Baseline and 12 weeks Mean changes in energy and protein intake, assessed by the 24 hour recording
Occurrence of complications due to radiotherapy 12 weeks Number of patients with complications due to radiotherapy, assessed from medical record
Fat free mass Baseline and 12 weeks Mean changes in fat free mass, assessed by foot-to-foot bioimpedance
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 unplanned hospitalization 12 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
🇧🇷Alfenas, Minas Gerais, Brazil
Fundação Hospitalar do Município de Varginha - Hospital Bom Pastor
🇧🇷Varginha, Minas Gerais, Brazil