Effects of Nutritional Counseling on Nutritional Status and Quality of Life of Head and Neck Cancer Patients

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03114202
• Other study ID #: 1.954.066
• Status: Recruiting
• Phase: N/A
• First received: March 23, 2017
• Last updated: July 14, 2017
• Start date: April 18, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: March 2017
• Source: University of Sao Paulo General Hospital
• Contact: Jose Eluf Neto
• Phone: +55(11)3061-8278
• Email: jose.eluf[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Other:
• intensive nutritional counseling
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.
• Standard care
Nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

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