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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Centre Henri Becquerel

    Rouen, 76038

Other trials in France

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

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 groups in NCT02900963
Study groupRoleWhat they receive
Nutrition state determinationOtherDetermination 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.

  1. weight

    Measure of weight ( in Kg)

    Measured: one year

Secondary outcomes (13)
  1. Nutritional status determination

    Determination of nutritional status by assessing albuminemia

    Measured: 3 months

  2. Nutritional status determination

    Determination of nutritional status by assessing transthyretin

    Measured: 3 months

  3. Nutritional status determination

    Determination of nutritional status by assessing albuminemia

    Measured: 6 months

  4. Nutritional status determination

    Determination of nutritional status by assessing transthyretin

    Measured: 6 months

  5. Nutritional status determination

    Determination of nutritional status by assessing albuminemia

    Measured: One year

  6. Nutritional status determination

    Determination of nutritional status by assessing transthyretin

    Measured: One year

  7. Inflammatory status

    Determination of inflammatory status by assessing orosomucoid

    Measured: 3 months

  8. Inflammatory status

    Determination of inflammatory status by assessing CRP

    Measured: 3 months

  9. Inflammatory status

    Determination of inflammatory status by assessing orosomucoid

    Measured: 6 months

  10. Inflammatory status

    Determination of inflammatory status by assessing CRP

    Measured: 6 months

  11. Inflammatory status

    Determination of inflammatory status by assessing orosomucoid

    Measured: one year

  12. Inflammatory status

    Determination of inflammatory status by assessing CRP

    Measured: one year

  13. 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.

  1. First posted15 Sep 2016 (estimated)
  2. Study startApr 2014
  3. Primary completionAug 2018
  4. Study completionDec 2018

Resources

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)
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

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.

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