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

Carcinoma, Squamous Cell of Head and Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01876693
• Other study ID #: si041/2013
• Status: Recruiting
• Phase: N/A
• First received: May 21, 2013
• Last updated: April 6, 2015
• Start date: May 2013
• Est. completion date: September 2015

Study information

• Verified date: April 2015
• Source: Mahidol University
• Contact: Suthinee Ithimakin, MD
• Phone: 662-419-4489
• Email: aesi105[@]yahoo.co.th
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Carcinoma, Squamous Cell of Head and Neck
• Head and Neck Neoplasms

Intervention

Procedure:
• prophylactic percutaneous gastrostomy
prophylactic percutaneous gastrostomy with nutrition counselling

Locations

Country	Name	City	State
Thailand	Division of medical oncology, department of medicine Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment interruption due to toxicity		during period of chemoradiatherapy, an expected average of 6 weeks	No
Secondary	quality of life		during period of chemoradiation, an expected avearage of 6 weeks	No