A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy
NCT ID: NCT01876693
Last Updated: 2016-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
95 participants
INTERVENTIONAL
2013-05-31
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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control
nutrition counselling with nasogastric tube insertion in the cases of weight loss more than 10% or severe mucositis developed during chemoradiotherapy
No interventions assigned to this group
prophylactic percutaneous gastrostomy
prophylactic percutaneous gastrostomy with nutrition counselling
prophylactic percutaneous gastrostomy
prophylactic percutaneous gastrostomy with nutrition counselling
Interventions
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prophylactic percutaneous gastrostomy
prophylactic percutaneous gastrostomy with nutrition counselling
Eligibility Criteria
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Inclusion Criteria
* plan to have chemoradiotherapy session
* Performance status of 0-2
Exclusion Criteria
* Body mass index less than 16 kg/m2
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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suthinee ithimakin
Assistant professor
Principal Investigators
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Suthinee Ithimakin, MD
Role: PRINCIPAL_INVESTIGATOR
Siriraj Hospital
Locations
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Division of medical oncology, department of medicine Siriraj Hospital
Bangkok, , Thailand
Countries
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References
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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.
Other Identifiers
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si041/2013
Identifier Type: -
Identifier Source: org_study_id
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