Normalcy of Food Intake in Head and Neck Cancer Patients

Study Overview
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Brief Summary
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Background: Oral nutrition appears to be a challenge for patients with head and neck cancer after radiotherapy. Many patients desire to (their) 'normal food intake' and return to oral nutrition with normal consistency without modifications and diet formulas. Due to the dysphagia experienced post treatment this seems tremendously difficult. Referral to a speech-language therapist for swallowing therapy is no standard procedure. Study design: A prospective randomized study in patients with a tumor in Oral cavity, Nasopharynx, Oropharynx, Hypopharynx or Larynx with stage II-IV (UICC TNM-tumor classification), ≥ 18 years, eligible for primary treatment with (chemo)radiation or adjuvant radiotherapy with curative intent. Intervention: Individually tailored swallowing therapy by an experienced speech-language therapist in cooperation with individual dietary counselling (by an experienced dietician, 'usual care') pre-, per- and post treatment (until 6 months after treatment). This might improve 'normalcy of food intake', quality (no food modifications) and quantity of food intake and besides decrease the use of tube feeding and/or nutritional supplements. Also patients quality of life and nutritional status may be influenced positively. Study hypothesis: The purpose of this study is to determine whether combined individual swallowing therapy and individual dietary counselling in patients with head and neck cancer receiving (chemo)radiotherapy can improve 'normal food intake'. Food intake without modifications and tube feeding and/or nutritional supplements.

Official Title
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Normalcy of Food Intake in Head and Neck Cancer Patients Receiving (Chemo)Radiotherapy Supported by Swallowing Therapy and Individual Dietary Counselling. (Supportive Care)

Conditions
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Neoplasms, Head and Neck

Intervention / Treatment
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* Other: Swallow therapy in combination with individual dietary counselling
* Other: Individual dietary counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with tumor in oral cavity, nasopharynx, hypopharynx or larynx with stage II-IV (UICC TNM-tumor classification) Eligible for primary curative treatment intentions with (chemo)radiation or adjuvant (chemo)radiotherapy A signed informed consent Exclusion Criteria: Historical swallowing problems (neurological or not tumor related) Unable to comprehend and carry out the swallowing rehabilitation Unable to answer study questions Radiation or surgery for head and neck cancer in history.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Swallowing therapy<br>Swallowing therapy in combination with individual dietary counselling | Other: Swallow therapy in combination with individual dietary counselling<br>* Weekly swallowing therapy (by speech language therapist) from start of (chemo)radiation until 6 months after last (chemo)radiation. Weekly Individual dietary counselling (by dietician) form the start of (chemo) radiotherapy until 6 months after last (chemo)radiation. With close interaction between the both interventions.<br>* Other names: PST+IDC;|
| Active Comparator: Individual dietary counselling<br>Swallowing therapy only on indication. (usual care) | Other: Individual dietary counselling<br>* Weekly Individual dietary counselling form the start of (chemo) radiotherapy until 6 months after last (chemo)radiation.<br>* Other names: IDC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalcy of food intake | Increase of normalcy of food intake of 10% | within 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | within 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck neoplasms, Radiotherapy, Diet counselling, Swallow therapy, Food intake