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

March 29, 2016 updated by: suthinee ithimakin, Mahidol University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Division of medical oncology, department of medicine Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
nutrition counselling with nasogastric tube insertion in the cases of weight loss more than 10% or severe mucositis developed during chemoradiotherapy
Experimental: prophylactic percutaneous gastrostomy
prophylactic percutaneous gastrostomy with nutrition counselling
Procedure: prophylactic percutaneous gastrostomy
prophylactic percutaneous gastrostomy with nutrition counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
treatment interruption due to toxicity
Time Frame: during period of chemoradiatherapy, an expected average of 6 weeks
during period of chemoradiatherapy, an expected average of 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life
Time Frame: during period of chemoradiation, an expected avearage of 6 weeks
during period of chemoradiation, an expected avearage of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Suthinee Ithimakin, MD, Faculty of Medicine Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • si041/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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