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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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ClinicalTrials.gov Identifier: NCT03114202
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Other: intensive nutritional counseling Other: Standard care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Intensive Nutritional Counseling on Nutritional Status and Quality of Life of Patients With Head and Neck Cancer Undergoing Radiation Therapy
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : August 6, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. Change in weight [ Time Frame: Baseline and 12 weeks ]
    Defined as mean weight change

  2. Change in nutritional status [ Time Frame: Baseline and 12 weeks ]
    Defined as mean body mass index change

  3. 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).


Secondary Outcome Measures :
  1. 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)

  2. Energy and protein intake [ Time Frame: Baseline and 12 weeks ]
    Mean changes in energy and protein intake, assessed by the 24 hour recording

  3. Fat free mass [ Time Frame: Baseline and 12 weeks ]
    Mean changes in fat free mass, assessed by foot-to-foot bioimpedance

  4. Occurrence of complications due to radiotherapy [ Time Frame: 12 weeks ]
    Number of patients with complications due to radiotherapy, assessed from medical record

  5. Occurrence of unplanned hospitalization [ Time Frame: 12 weeks ]
    Number of patients with unplanned hospitalization, assessed from medical record

  6. Occurrence of interruption or delay in treatment. [ Time Frame: 12 weeks ]
    Number of patients with interruption or delay in treatment, assessed from medical records



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114202


Contacts
Contact: Jose Eluf Neto +55(11)3061-8278 jose.eluf@hc.fm.usp.br
Contact: Sheilla Faria +55(35)3701-9745 shefaria@hotmail.com

Locations
Brazil
Centro de Oncologia da Santa Casa Nossa Senhora do Perpétuo Socorro Recruiting
Alfenas, Minas Gerais, Brazil, 37130-081
Contact: Sheilla Faria    +55(35)37019745    shefaria@hotmail.com   
Principal Investigator: Sheilla Faria         
Fundação Hospitalar do Município de Varginha - Hospital Bom Pastor Recruiting
Varginha, Minas Gerais, Brazil, 37014-460
Contact: Sheilla Faria    +55(35)37019745    shefaria@hotmail.com   
Principal Investigator: Sheilla Faria         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Jose Eluf Neto São Paulo University
Study Chair: Andre Carvalho Hospital de Cancer de Barretos - Fundação PIO XII
Study Chair: Sheilla Faria São Paulo University

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03114202     History of Changes
Other Study ID Numbers: 1.954.066
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms