Nutritional Status Assessment in Head and Neck Cancer Patients Receiving Radiotherapy or Chemo-radiotherapy
Nutritional Status Assessment in Head and Neck Cancer Patients Receiving 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.
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
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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.