Head and Neck Neoplasms Clinical Trial
Official title:
Effects of Intensive Nutritional Counseling on Nutritional Status and Quality of Life of Patients With Head and Neck Cancer Undergoing Radiation Therapy
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | October 1, 2018 |
Est. primary completion date | August 6, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | 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 |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in weight | Defined as mean weight change | Baseline and 12 weeks | |
Primary | Change in nutritional status | Defined as mean body mass index change | Baseline and 12 weeks | |
Primary | Change in quality of life | 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). | Baseline and 12 weeks | |
Secondary | Change in patient generated subjective global assessment | Self reported nutritional assessment by the Scored Patient-Generated Subjective Global Assessment (PG-SGA) | Baseline and 12 weeks | |
Secondary | Energy and protein intake | Mean changes in energy and protein intake, assessed by the 24 hour recording | Baseline and 12 weeks | |
Secondary | Fat free mass | Mean changes in fat free mass, assessed by foot-to-foot bioimpedance | Baseline and 12 weeks | |
Secondary | Occurrence of complications due to radiotherapy | Number of patients with complications due to radiotherapy, assessed from medical record | 12 weeks | |
Secondary | Occurrence of unplanned hospitalization | Number of patients with unplanned hospitalization, assessed from medical record | 12 weeks | |
Secondary | Occurrence of interruption or delay in treatment. | Number of patients with interruption or delay in treatment, assessed from medical records | 12 weeks |
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