A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy

Study Overview
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Brief Summary
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The purpose of the study is to determine whether prophylactic gastrostomy leads to less treatment interruption and provide better quality of life in head and neck cancer patients receiving chemoradiotherapy.

Detailed Description
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Nutritional status is one of the essential factor to determine outcome of chemoradiotherapy in head and neck cancer patients. Almost all these patients develop mucositis during the treatment, which usually leads to treatment interruptions and affects the efficacy of the treatment. Prophylactic gastrostomy has been accepted for these patients with improvement of quality of life. However, there is no prospective study confirming superiority of such treatment. The investigators enrolled head and neck cancer patients who had the plan of chemoradiotherapy. The patients will be informed about both treatment arms and will decide the arm that they preferred. The treatment interruptions, body weight and nutritional status will be assessed every 2 weeks during treatment period.

Official Title
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A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy in Medical Practice

Conditions
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Carcinoma, Squamous Cell of Head and Neck

Intervention / Treatment
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* Procedure: prophylactic percutaneous gastrostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathologically confirmed of head and neck cancer plan to have chemoradiotherapy session Performance status of 0-2 Exclusion Criteria: contraindications for percutaneous gastrostomy, eg coagulopathy, obstructed tumor Body mass index less than 16 kg/m2

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>nutrition counselling with nasogastric tube insertion in the cases of weight loss more than 10% or severe mucositis developed during chemoradiotherapy | |
| Experimental: prophylactic percutaneous gastrostomy<br>prophylactic percutaneous gastrostomy with nutrition counselling | Procedure: prophylactic percutaneous gastrostomy<br>* prophylactic percutaneous gastrostomy with nutrition counselling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment interruption due to toxicity |  | during period of chemoradiatherapy, an expected average of 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | during period of chemoradiation, an expected avearage of 6 weeks |