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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03114202
Other study ID # 1.954.066
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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