NCT01876693

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Carcinoma, Squamous Cell of Head and Neck

Interventions

Type	Name	Description
PROCEDURE	prophylactic percutaneous gastrostomy	prophylactic percutaneous gastrostomy with nutrition counselling

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-02-01
• Completion: 2015-06-01
• First posted: 2013-06-12
• Last updated: 2016-03-31

Locations

1 site across 1 country: Thailand