A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy in Medical Practice
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
treatment interruption due to toxicity
during period of chemoradiatherapy, an expected average of 6 weeks
No
Suthinee Ithimakin, MD
Principal Investigator
Faculty of medicine Siriraj Hospital
Thailand: Ethical Committee
si041/2013
NCT01876693
May 2013
September 2015
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