Head and Neck CancerNUTRINECKNCT02900963
Nutritional Status Assessment in Head and Neck Cancer Patients Receiving Radiotherapy or Chemo-radiotherapy
A study testing weekly assessment of patient's weight in people with Head and Neck Cancer, run by Centre Henri Becquerel at 1 site in France.
Trial summary
Radiotherapy and chemotherapy are standard treatment of head and neck cancer alone or associated to surgical treatment. Early (during treatment or the following weeks) and late side effects contribute to malnutrition in this population at risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- weekly assessment of patient's weight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Dec 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
- Males or females older than 18 years
- Performance Status 0 or 1 or 2
- Locally advanced head and neck cancer treated with a curative intent treatment consisting of either concomitant chemo-radiotherapy or adjuvant radiation therapy or adjuvant chemo-radiotherapy.
- Signed Informed Consent
Who cannot join
- Other cancer or previous cancer within 2 years or evolutive cancer
- Performance Status 3 or 4
- NGT or PEG at screening period
- Any legal, social, psychological reasons that could jeopardize the patient's compliance to the study constrains.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Assessment of Locally Advanced Head and Neck Cancer Patients Who Underwent Exclusive or Adjuvant Radiotherapy or Chemo-radiotherapy
Radiotherapy and chemotherapy are standard treatment of head and neck cancer alone or associated to surgical treatment. Early (during treatment or the following weeks) and late side effects contribute to malnutrition in this population at risk. In this context, nutritional support adapted by dietary monitoring and enteral nutrition (nasogastric tube or gastrostomy) are often necessary. The early identification of the patients with high malnutrition risk and requiring enteral nutrition is necessary to improve the tolerance and efficacy of treatment. This prospective study research the factors of malnutrition during head and neck radiotherapy.
Read the detailed description
Head and neck cancer is one of the most common malignancies in the world, Malnutrition occurs frequently at the time of diagnosis as consequences of alcohol consumption and tobacco use that is quite common in this patients population, and of local tumor invasion, obstructing the function of swallowing and chewing. In addition, during the treatment, mucositis, anorexia, dysphagia, mouth sores, and other acute and late toxic effects of radiotherapy (RT) and chemotherapy frequently worsen the nutritional status.
Poor nutritional status and chemotherapy or RT-toxicity, lead to treatment interruption frequently and is also associated with higher risk of infection, hospital readmission, early death, worse survival outcomes, and deterioration in the quality of life (QoL). According to published results, one third of the patient would have benefit from a complete treatment. In addition, the correlation exists between some biological parameters (CRP, albumin, neutrophils, Hb) and the nutritional status. Therefore, it deems essential to maintain nutritional status in head and neck cancer patients undergoing RT and chemotherapy.
Dietary counseling and oral supplements showed positive influences on nutritional outcomes and QoL However, their role is limited when it comes to obstruction or mucositis. Thus, enteral feeding may be a choice either through nasogastric tube (NGT) or percutaneous endoscopic gastrostomy (PEG). Studies investigated the effects of PEG compared with NGT were not conclusive or showing no consistent results on nutritional status, treatment interruption, nutrition-related hospital admission, and tube-related complications in the head and neck cancer patients receiving RT or chemo-radiotherapy.
The optimal method and the timing of placement are still debated. Consequently, the aim of this study is to collect data on our current daily practice on supplementary nutrition method ( NGT, PEG) in head and neck cancers patients treated in our radiation therapy unit and to identify factors predicting good treatment outcomes( ie full treatment administration).
Secondary objectives are to collect nutritional data during the treatment, to study the nutritional status in relation to acute or late adverse events, to study the impact of an early enteral feeding on clinical and biological parameters.
Ancillary study: Sarco-Nutrineck The aim of this ancillary study is to collect data on prevalence of low muscle mass in this population, treatment outcomes and survival.
Study measures:
At baseline: body height and weight, calculated BMI. Biological parameters: albumin, orosomucoid, transthyretin, CRP Daily - during the treatment period: weight Weekly - during the treatment period: albumin, orosomucoid, transthyretin, CRP. The Nutritional and inflammatory status score will be calculated.
Clinical criteria on the requirement of enteral nutrition (or need for artificial nutrition) in case of weight loss persisting at least for three days during radiotherapy:
The aim of this study is to investigate whether nutritional screening on admission can be used to determine risk levels for adverse clinical events and treatment outcome ( full treatment administration) in head and neck cancer and to propose a risk stratification based on nutritional screening before radiotherapy or concomitant chemo radiotherapy.
tube (NGT) will be placed according to the following procedure: The weight will be assessed on daily basis and will be compared to the figure at baseline, before treatment. If the weight loss is superior to 2 kg, the patient will consult a radiotherapist who will perform a physical examination, a nutritional assessment (history, appetite change, taste, quantity and quality of oral food intake, medication, details regarding weight change and BMI). In addition to dietary counselling and oral supplementation, If indicated, analgesic drugs and or treatment of associated mucositis will be prescribed.
In case of persisting weight loss or severe dysphagia or no oral solid food intake, a nasogastric tube (NGT) will be placed by a nurse and a personalized nutritional counselling by a dietician will be organized.
Biological exams will be done according to our local practice and standard, and the results will be analyzed to assess the safety. Regular clinical exams will be realized. All adverse events will reported according to the common terminology criteria for adverse events scale.
Follow-up period. The patients will benefit from a clinical exam, height, weight, BMI, biological exam (including albumin, orosomucoid, transthyretin, CRP) one month after the end of the treatment, and then at three months and at twelve months, late toxicities will be recorded.
The aim of this study is to investigate whether nutritional screening on admission can be used to determine risk levels for adverse clinical events and treatment outcome (full treatment administration) in head and neck cancer and to propose i) isk stratification based on nutritional screening before radiotherapy or concomitant chemo radiotherapy ii) decisional algorithm on placement of a NGT
- Conditions
- Head and Neck Cancer
- Being tested
- weekly assessment of patient's weight
- Keywords
- Nutrition, Head and Neck Cancer
- 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.
weekly assessment of patient's weightOther
Biological assessment to determine biological and inflammatory status Quality of life questionary
| Study group | Role | What they receive |
|---|---|---|
| Nutrition state determination | Other | Determination of nutritional state and inflammatory status:
weekly assessment of patient's weight biological parameters (albumin, transthyretin, orosomucoid) and weekly assessment of patient's weight Receives: Other: weekly assessment of patient's weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Measure of weight ( in Kg)
Measured: one year
Secondary outcomes (13)
Nutritional status determination
Determination of nutritional status by assessing albuminemia
Measured: 3 months
Nutritional status determination
Determination of nutritional status by assessing transthyretin
Measured: 3 months
Nutritional status determination
Determination of nutritional status by assessing albuminemia
Measured: 6 months
Nutritional status determination
Determination of nutritional status by assessing transthyretin
Measured: 6 months
Nutritional status determination
Determination of nutritional status by assessing albuminemia
Measured: One year
Nutritional status determination
Determination of nutritional status by assessing transthyretin
Measured: One year
Inflammatory status
Determination of inflammatory status by assessing orosomucoid
Measured: 3 months
Inflammatory status
Determination of inflammatory status by assessing CRP
Measured: 3 months
Inflammatory status
Determination of inflammatory status by assessing orosomucoid
Measured: 6 months
Inflammatory status
Determination of inflammatory status by assessing CRP
Measured: 6 months
Inflammatory status
Determination of inflammatory status by assessing orosomucoid
Measured: one year
Inflammatory status
Determination of inflammatory status by assessing CRP
Measured: one year
BMI calculation
Calculation of BMI using height and weight
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startApr 2014
- Primary completionAug 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien Thureau, MD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900963
- Sponsor's protocol ID
- CHB 13.04
- Acronym
- NUTRINECK
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2016
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assessment of Locally Advanced Head and Neck Cancer Patients Who Underwent Exclusive or Adjuvant Radiotherapy or Chemo-radiotherapy
- ClinicalTrials.gov ID
- NCT02900963
- Acronym / sponsor ID
- NUTRINECK / CHB 13.04
- Conditions
- Head and Neck Cancer
- Keywords
- Nutrition, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 Sep 2016 (estimated)
- 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.
Radiotherapy and chemotherapy are standard treatment of head and neck cancer alone or associated to surgical treatment. Early (during treatment or the following weeks) and late side effects contribute to malnutrition in this population at risk. In this context, nutritional support adapted by dietary monitoring and enteral nutrition (nasogastric tube or gastrostomy) are often necessary. The early identification of the patients with high malnutrition risk and requiring enteral nutrition is necessary to improve the tolerance and efficacy of treatment. This prospective study research the factors of malnutrition during head and neck radiotherapy.
Detailed description
Head and neck cancer is one of the most common malignancies in the world, Malnutrition occurs frequently at the time of diagnosis as consequences of alcohol consumption and tobacco use that is quite common in this patients population, and of local tumor invasion, obstructing the function of swallowing and chewing. In addition, during the treatment, mucositis, anorexia, dysphagia, mouth sores, and other acute and late toxic effects of radiotherapy (RT) and chemotherapy frequently worsen the nutritional status.
Poor nutritional status and chemotherapy or RT-toxicity, lead to treatment interruption frequently and is also associated with higher risk of infection, hospital readmission, early death, worse survival outcomes, and deterioration in the quality of life (QoL). According to published results, one third of the patient would have benefit from a complete treatment. In addition, the correlation exists between some biological parameters (CRP, albumin, neutrophils, Hb) and the nutritional status. Therefore, it deems essential to maintain nutritional status in head and neck cancer patients undergoing RT and chemotherapy.
Dietary counseling and oral supplements showed positive influences on nutritional outcomes and QoL However, their role is limited when it comes to obstruction or mucositis. Thus, enteral feeding may be a choice either through nasogastric tube (NGT) or percutaneous endoscopic gastrostomy (PEG). Studies investigated the effects of PEG compared with NGT were not conclusive or showing no consistent results on nutritional status, treatment interruption, nutrition-related hospital admission, and tube-related complications in the head and neck cancer patients receiving RT or chemo-radiotherapy.
The optimal method and the timing of placement are still debated. Consequently, the aim of this study is to collect data on our current daily practice on supplementary nutrition method ( NGT, PEG) in head and neck cancers patients treated in our radiation therapy unit and to identify factors predicting good treatment outcomes( ie full treatment administration).
Secondary objectives are to collect nutritional data during the treatment, to study the nutritional status in relation to acute or late adverse events, to study the impact of an early enteral feeding on clinical and biological parameters.
Ancillary study: Sarco-Nutrineck The aim of this ancillary study is to collect data on prevalence of low muscle mass in this population, treatment outcomes and survival.
Study measures:
At baseline: body height and weight, calculated BMI. Biological parameters: albumin, orosomucoid, transthyretin, CRP Daily - during the treatment period: weight Weekly - during the treatment period: albumin, orosomucoid, transthyretin, CRP. The Nutritional and inflammatory status score will be calculated.
Clinical criteria on the requirement of enteral nutrition (or need for artificial nutrition) in case of weight loss persisting at least for three days during radiotherapy:
The aim of this study is to investigate whether nutritional screening on admission can be used to determine risk levels for adverse clinical events and treatment outcome ( full treatment administration) in head and neck cancer and to propose a risk stratification based on nutritional screening before radiotherapy or concomitant chemo radiotherapy.
tube (NGT) will be placed according to the following procedure: The weight will be assessed on daily basis and will be compared to the figure at baseline, before treatment. If the weight loss is superior to 2 kg, the patient will consult a radiotherapist who will perform a physical examination, a nutritional assessment (history, appetite change, taste, quantity and quality of oral food intake, medication, details regarding weight change and BMI). In addition to dietary counselling and oral supplementation, If indicated, analgesic drugs and or treatment of associated mucositis will be prescribed.
In case of persisting weight loss or severe dysphagia or no oral solid food intake, a nasogastric tube (NGT) will be placed by a nurse and a personalized nutritional counselling by a dietician will be organized.
Biological exams will be done according to our local practice and standard, and the results will be analyzed to assess the safety. Regular clinical exams will be realized. All adverse events will reported according to the common terminology criteria for adverse events scale.
Follow-up period. The patients will benefit from a clinical exam, height, weight, BMI, biological exam (including albumin, orosomucoid, transthyretin, CRP) one month after the end of the treatment, and then at three months and at twelve months, late toxicities will be recorded.
The aim of this study is to investigate whether nutritional screening on admission can be used to determine risk levels for adverse clinical events and treatment outcome (full treatment administration) in head and neck cancer and to propose i) isk stratification based on nutritional screening before radiotherapy or concomitant chemo radiotherapy ii) decisional algorithm on placement of a NGT
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition state determination | Other | Other: weekly assessment of patient's weightDetermination of nutritional state and inflammatory status: weekly assessment of patient's weight biological parameters (albumin, transthyretin, orosomucoid) and weekly assessment of patient's weight |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females older than 18 years
- Performance Status 0 or 1 or 2
- Locally advanced head and neck cancer treated with a curative intent treatment consisting of either concomitant chemo-radiotherapy or adjuvant radiation therapy or adjuvant chemo-radiotherapy.
- Signed Informed Consent
Key exclusion criteria (4 listed)
- Other cancer or previous cancer within 2 years or evolutive cancer
- Performance Status 3 or 4
- NGT or PEG at screening period
- Any legal, social, psychological reasons that could jeopardize the patient's compliance to the study constrains.
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 |
|---|---|---|
| weekly assessment of patient's weightBiological assessment to determine biological and inflammatory status Quality of life questionary | Other | Nutrition state determination |
Primary outcome
weight
Time frame: one year
Measure of weight ( in Kg)
13 secondary outcomes
Nutritional status determination
Time frame: 3 months
Nutritional status determination
Time frame: 3 months
Nutritional status determination
Time frame: 6 months
Nutritional status determination
Time frame: 6 months
Nutritional status determination
Time frame: One year
Nutritional status determination
Time frame: One year
Inflammatory status
Time frame: 3 months
Inflammatory status
Time frame: 3 months
Inflammatory status
Time frame: 6 months
Inflammatory status
Time frame: 6 months
Inflammatory status
Time frame: one year
Inflammatory status
Time frame: one year
BMI calculation
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Sebastien Thureau, MD principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weekly assessment of patient's weight in people with Head and Neck Cancer, run by Centre Henri Becquerel at 1 site in France.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: one year). 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 30 Jul 2020.