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

Mahidol University

Status: Terminated

Conditions: Carcinoma, Squamous Cell of Head and Neck

Treatments: Procedure: prophylactic percutaneous gastrostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01876693

si041/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

control

No Intervention group

Description:

nutrition counselling with nasogastric tube insertion in the cases of weight loss more than 10% or severe mucositis developed during chemoradiotherapy

prophylactic percutaneous gastrostomy

Experimental group

Description:

prophylactic percutaneous gastrostomy with nutrition counselling

Treatment:

Procedure: prophylactic percutaneous gastrostomy