NCT03114202

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

April 18, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

July 19, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

March 23, 2017

Last Update Submit

July 14, 2017

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (3)

  • Change in weight

    Defined as mean weight change

    Baseline and 12 weeks

  • Change in nutritional status

    Defined as mean body mass index change

    Baseline and 12 weeks

  • 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 Outcomes (6)

  • Change in patient generated subjective global assessment

    Baseline and 12 weeks

  • Energy and protein intake

    Baseline and 12 weeks

  • Fat free mass

    Baseline and 12 weeks

  • Occurrence of complications due to radiotherapy

    12 weeks

  • Occurrence of unplanned hospitalization

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: intensive nutritional counseling

Control group

OTHER

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

Other: Standard care

Interventions

intensive nutritional counselingOTHER

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 group
Standard careOTHER

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Patients using parenteral nutrition; without cognitive ability to understand the concepts of the questionnaires; in palliative radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro de Oncologia da Santa Casa Nossa Senhora do Perpétuo Socorro

Alfenas, Minas Gerais, 37130-081, Brazil

RECRUITING

Fundação Hospitalar do Município de Varginha - Hospital Bom Pastor

Varginha, Minas Gerais, 37014-460, Brazil

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jose Eluf Neto

    São Paulo University

    PRINCIPAL INVESTIGATOR

  • Andre Carvalho

    Hospital de Cancer de Barretos - Fundação PIO XII

    STUDY CHAIR

  • Sheilla Faria

    São Paulo University

    STUDY CHAIR

Central Study Contacts

Jose Eluf Neto

CONTACT

+55(11)3061-8278jose.eluf@hc.fm.usp.br

Sheilla Faria

CONTACT

+55(35)3701-9745shefaria@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2017

First Posted

April 14, 2017

Study Start

April 18, 2017

Primary Completion

August 6, 2018

Study Completion

October 1, 2018

Last Updated

July 19, 2017

Record last verified: 2017-03

Locations

BR(2)