Head and Neck NeoplasmsNCT03114202
Effects of Nutritional Counseling on Nutritional Status and Quality of Life of Head and Neck Cancer Patients
A study testing intensive nutritional counseling in people with Head and Neck Neoplasms, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- intensive nutritional counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesBrazil
- Study dates
- 18 Apr 2017to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Patients using parenteral nutrition; without cognitive ability to understand the concepts of the questionnaires; in palliative radiotherapy.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Centro de Oncologia da Santa Casa Nossa Senhora do Perpétuo Socorro
Alfenas, Minas Gerais, 37130-081
Sheilla Faria, +55(35)37019745, shefaria@hotmail.com
Sheilla Faria
- Recruiting
Fundação Hospitalar do Município de Varginha - Hospital Bom Pastor
Varginha, Minas Gerais, 37014-460
Sheilla Faria, +55(35)37019745, shefaria@hotmail.com
Sheilla Faria
About this study
Official title: 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.
Read the 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).
- Conditions
- Head and Neck Neoplasms
- Being tested
- intensive nutritional counseling, Standard care
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard careOther
Nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intensive nutritional counseling: once they are admitted to the study and once a week during radiotherapy Receives: Other: intensive nutritional counseling |
| Control group | Other | Standard care: when there is demand, usually 1 to 2 times during radiotherapy Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Defined as mean weight change
Measured: Baseline and 12 weeks
Change in nutritional status
Defined as mean body mass index change
Measured: 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).
Measured: Baseline and 12 weeks
Secondary outcomes (6)
Change in patient generated subjective global assessment
Self reported nutritional assessment by the Scored Patient-Generated Subjective Global Assessment (PG-SGA)
Measured: Baseline and 12 weeks
Energy and protein intake
Mean changes in energy and protein intake, assessed by the 24 hour recording
Measured: Baseline and 12 weeks
Fat free mass
Mean changes in fat free mass, assessed by foot-to-foot bioimpedance
Measured: Baseline and 12 weeks
Occurrence of complications due to radiotherapy
Number of patients with complications due to radiotherapy, assessed from medical record
Measured: 12 weeks
Occurrence of unplanned hospitalization
Number of patients with unplanned hospitalization, assessed from medical record
Measured: 12 weeks
Occurrence of interruption or delay in treatment.
Number of patients with interruption or delay in treatment, assessed from medical records
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start18 Apr 2017
- Primary completion6 Aug 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Eluf Neto, Principal investigator, São Paulo UniversityAndre Carvalho, Study chair, Hospital de Cancer de Barretos - Fundação PIO XIISheilla Faria, Study chair, São Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114202
- Sponsor's protocol ID
- 1.954.066
- Status last verified
- Mar 2017
- First submitted
- 23 Mar 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Nutritional Counseling on Nutritional Status and Quality of Life of Patients With Head and Neck Cancer Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT03114202
- Acronym / sponsor ID
- 1.954.066
- Conditions
- Head and Neck Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 6 Aug 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: intensive nutritional counselingIntensive nutritional counseling: once they are admitted to the study and once a week during radiotherapy |
| Control group | Other | Other: Standard careStandard care: when there is demand, usually 1 to 2 times during radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients using parenteral nutrition; without cognitive ability to understand the concepts of the questionnaires; in palliative radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensive nutritional counselingIndividualised 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 | Intervention group |
| Standard careNutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist. | Other | Control group |
Primary outcome
Change in weight
Time frame: Baseline and 12 weeks
Defined as mean weight change
Change in nutritional status
Time frame: Baseline and 12 weeks
Defined as mean body mass index change
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).
6 secondary outcomes
Change in patient generated subjective global assessment
Time frame: Baseline and 12 weeks
Energy and protein intake
Time frame: Baseline and 12 weeks
Fat free mass
Time frame: Baseline and 12 weeks
Occurrence of complications due to radiotherapy
Time frame: 12 weeks
Occurrence of unplanned hospitalization
Time frame: 12 weeks
Occurrence of interruption or delay in treatment.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Head and Neck Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Study of Neurocognitive Tests and Questionnaires for People With Head and Neck Cancer Who Are Undergoing Radiation Therapy
Head and Neck Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Eluf Neto principal investigator
São Paulo University
Andre Carvalho study chair
Hospital de Cancer de Barretos - Fundação PIO XII
Sheilla Faria study chair
São Paulo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive nutritional counseling in people with Head and Neck Neoplasms, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose Eluf Neto (+55(11)3061-8278, jose.eluf@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.