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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-18

Study Completion Date

2018-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intensive Nutrition Counselling in Patients With Head and Neck Cancer

NCT02159508

Head and Neck Squamous Cell Cancer

UNKNOWN NA

Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy

NCT01210872

Head and Neck Cancer

UNKNOWN

Physical Activity Program and Nutrition Therapeutic Education During Treatment of Head and Neck Cancer Population

NCT01910753

Neck Cancer

TERMINATED NA

Resistance Training and Physical Functioning in Head and Neck Cancer Patients

NCT01332682

Head and Neck Cancer Pharyngeal Cancer Laryngeal Cancer

COMPLETED PHASE1

Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness

NCT03089736

Pain Head and Neck Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

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

Group Type EXPERIMENTAL

intensive nutritional counseling

Intervention Type OTHER

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.

Control group

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

Group Type OTHER

Standard care

Intervention Type OTHER

Nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Standard care

Nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).