Effects of Intensive Nutritional Counseling on Nutritional Status and Quality of Life of Patients With Head and Neck Cancer Undergoing Radiation Therapy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Head and Neck Neoplasms
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Change in quality of life
- Last Updated
- 8 years ago
Overview
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).
Investigators
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.
Outcomes
Primary Outcomes
Change in quality of life
Time Frame: 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
Time Frame: Baseline and 12 weeks
Defined as mean weight change
Change in nutritional status
Time Frame: Baseline and 12 weeks
Defined as mean body mass index change
Secondary Outcomes
- Energy and protein intake(Baseline and 12 weeks)
- Occurrence of complications due to radiotherapy(12 weeks)
- Fat free mass(Baseline and 12 weeks)
- Change in patient generated subjective global assessment(Baseline and 12 weeks)
- Occurrence of unplanned hospitalization(12 weeks)
- Occurrence of interruption or delay in treatment.(12 weeks)