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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01876693
Other study ID # si041/2013
Secondary ID
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


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
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