A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy
Carcinoma, Squamous Cell of Head and Neck
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Study Type
Study Phase
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: prophylactic percutaneous gastrostomy
Type: Procedure
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Division of medical oncology, department of medicine Siriraj Hospital
Bangkok, Thailand
Status: Recruiting
Contact: Suthinee Ithimakin, MD - 662-419-4489 - aesi105@yahoo.co.th
Start Date
May 2013
Completion Date
September 2015
Mahidol University
Mahidol University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page