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

Not Applicable

Terminated

• Conditions: Carcinoma, Squamous Cell of Head and Neck
• Interventions: Procedure: prophylactic percutaneous gastrostomy

• Registration Number: NCT01876693
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-12
• Primary Completion: 2015-02
• Study Completion: 2015-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prophylactic percutaneous gastrostomy	prophylactic percutaneous gastrostomy	prophylactic percutaneous gastrostomy with nutrition counselling

Primary Outcome Measures

Name	Time	Method
treatment interruption due to toxicity	during period of chemoradiatherapy, an expected average of 6 weeks

Secondary Outcome Measures

Name	Time	Method
quality of life	during period of chemoradiation, an expected avearage of 6 weeks

Trial Locations

Locations (1)

Division of medical oncology, department of medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand