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slow accrual in experiment arm
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | nutrition counselling with nasogastric tube insertion in the cases of weight loss more than 10% or severe mucositis developed during chemoradiotherapy | |
| prophylactic percutaneous gastrostomy | Experimental | prophylactic percutaneous gastrostomy with nutrition counselling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prophylactic percutaneous gastrostomy | Procedure | prophylactic percutaneous gastrostomy with nutrition counselling |
|
| Measure | Description | Time Frame |
|---|---|---|
| treatment interruption due to toxicity | during period of chemoradiatherapy, an expected average of 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | during period of chemoradiation, an expected avearage of 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suthinee Ithimakin, MD | Siriraj Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of medical oncology, department of medicine Siriraj Hospital | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27028666 | Derived | Pramyothin P, Manyanont S, Trakarnsanga A, Petsuksiri J, Ithimakin S. A prospective study comparing prophylactic gastrostomy to nutritional counselling with a therapeutic feeding tube if required in head and neck cancer patients undergoing chemoradiotherapy in Thai real-world practice. J Hum Nutr Diet. 2016 Dec;29(6):768-776. doi: 10.1111/jhn.12377. Epub 2016 Mar 29. |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |