Carcinoma, Squamous Cell of Head and Neck
Conditions
Brief 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.
Interventions
PROCEDUREprophylactic percutaneous gastrostomy
prophylactic percutaneous gastrostomy with nutrition counselling
Sponsors
Mahidol University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment interruption due to toxicity | during period of chemoradiatherapy, an expected average of 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| quality of life | during period of chemoradiation, an expected avearage of 6 weeks |
Countries
Thailand
Outcome results
None listed