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

Primary Purpose

Head and Neck Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
intensive nutritional counseling
Standard care
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centro de Oncologia da Santa Casa Nossa Senhora do Perpétuo SocorroRecruiting
  • Fundação Hospitalar do Município de Varginha - Hospital Bom PastorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in weight
Defined as mean weight change
Change in nutritional status
Defined as mean body mass index change
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).

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2017
Last Updated
July 14, 2017
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03114202
Brief Title
Effects of Nutritional Counseling on Nutritional Status and Quality of Life of Head and Neck Cancer Patients
Official Title
Effects of Intensive Nutritional Counseling on Nutritional Status and Quality of Life of Patients With Head and Neck Cancer Undergoing Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
August 6, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intensive nutritional counseling: once they are admitted to the study and once a week during radiotherapy
Arm Title
Control group
Arm Type
Other
Arm Description
Standard care: when there is demand, usually 1 to 2 times during radiotherapy
Intervention Type
Other
Intervention Name(s)
intensive nutritional counseling
Intervention Description
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
Intervention Name(s)
Standard care
Intervention Description
Nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist.
Primary Outcome Measure Information:
Title
Change in weight
Description
Defined as mean weight change
Time Frame
Baseline and 12 weeks
Title
Change in nutritional status
Description
Defined as mean body mass index change
Time Frame
Baseline and 12 weeks
Title
Change in quality of life
Description
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).
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in patient generated subjective global assessment
Description
Self reported nutritional assessment by the Scored Patient-Generated Subjective Global Assessment (PG-SGA)
Time Frame
Baseline and 12 weeks
Title
Energy and protein intake
Description
Mean changes in energy and protein intake, assessed by the 24 hour recording
Time Frame
Baseline and 12 weeks
Title
Fat free mass
Description
Mean changes in fat free mass, assessed by foot-to-foot bioimpedance
Time Frame
Baseline and 12 weeks
Title
Occurrence of complications due to radiotherapy
Description
Number of patients with complications due to radiotherapy, assessed from medical record
Time Frame
12 weeks
Title
Occurrence of unplanned hospitalization
Description
Number of patients with unplanned hospitalization, assessed from medical record
Time Frame
12 weeks
Title
Occurrence of interruption or delay in treatment.
Description
Number of patients with interruption or delay in treatment, assessed from medical records
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Eluf Neto
Phone
+55(11)3061-8278
Email
jose.eluf@hc.fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Sheilla Faria
Phone
+55(35)3701-9745
Email
shefaria@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Eluf Neto
Organizational Affiliation
São Paulo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andre Carvalho
Organizational Affiliation
Hospital de Cancer de Barretos - Fundação PIO XII
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sheilla Faria
Organizational Affiliation
São Paulo University
Official's Role
Study Chair
Facility Information:
Facility Name
Centro de Oncologia da Santa Casa Nossa Senhora do Perpétuo Socorro
City
Alfenas
State/Province
Minas Gerais
ZIP/Postal Code
37130-081
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheilla Faria
Phone
+55(35)37019745
Email
shefaria@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sheilla Faria
Facility Name
Fundação Hospitalar do Município de Varginha - Hospital Bom Pastor
City
Varginha
State/Province
Minas Gerais
ZIP/Postal Code
37014-460
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheilla Faria
Phone
+55(35)37019745
Email
shefaria@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sheilla Faria

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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