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

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Head and Neck Neoplasms

Treatments: Other: intensive nutritional counseling; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT03114202

1.954.066

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Intervention group

Experimental group

Description:

Intensive nutritional counseling: once they are admitted to the study and once a week during radiotherapy

Treatment:

Other: intensive nutritional counseling

Control group

Other group

Description:

Standard care: when there is demand, usually 1 to 2 times during radiotherapy

Treatment:

Other: Standard care