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

July 14, 2017 updated by: University of Sao Paulo General Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Minas Gerais
      • Alfenas, Minas Gerais, Brazil, 37130-081
        • Recruiting
        • Centro de Oncologia da Santa Casa Nossa Senhora do Perpétuo Socorro
        • Contact:
        • Principal Investigator:
          • Sheilla Faria
      • Varginha, Minas Gerais, Brazil, 37014-460
        • Recruiting
        • Fundação Hospitalar do Município de Varginha - Hospital Bom Pastor
        • Contact:
        • Principal Investigator:
          • Sheilla Faria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
Intensive nutritional counseling: once they are admitted to the study and once a week during radiotherapy
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.
OTHER: Control group
Standard care: when there is demand, usually 1 to 2 times during radiotherapy
Other: Standard care
Nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight
Time Frame: Baseline and 12 weeks
Defined as mean weight change
Baseline and 12 weeks
Change in nutritional status
Time Frame: Baseline and 12 weeks
Defined as mean body mass index change
Baseline and 12 weeks
Change in quality of life
Time Frame: Baseline and 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient generated subjective global assessment
Time Frame: Baseline and 12 weeks
Self reported nutritional assessment by the Scored Patient-Generated Subjective Global Assessment (PG-SGA)
Baseline and 12 weeks
Energy and protein intake
Time Frame: Baseline and 12 weeks
Mean changes in energy and protein intake, assessed by the 24 hour recording
Baseline and 12 weeks
Fat free mass
Time Frame: Baseline and 12 weeks
Mean changes in fat free mass, assessed by foot-to-foot bioimpedance
Baseline and 12 weeks
Occurrence of complications due to radiotherapy
Time Frame: 12 weeks
Number of patients with complications due to radiotherapy, assessed from medical record
12 weeks
Occurrence of unplanned hospitalization
Time Frame: 12 weeks
Number of patients with unplanned hospitalization, assessed from medical record
12 weeks
Occurrence of interruption or delay in treatment.
Time Frame: 12 weeks
Number of patients with interruption or delay in treatment, assessed from medical records
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Jose Eluf Neto, Sao Paulo University
  • Study Chair: Andre Carvalho, Hospital de Cancer de Barretos - Fundacao Pio XII
  • Study Chair: Sheilla Faria, Sao Paulo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 18, 2017

Primary Completion (ANTICIPATED)

August 6, 2018

Study Completion (ANTICIPATED)

October 1, 2018

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (ACTUAL)

April 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 14, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.954.066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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