Back to resultsA Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy
Primary Purpose
Carcinoma, Squamous Cell of Head and Neck
Status
Terminated
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
prophylactic percutaneous gastrostomy
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Squamous Cell of Head and Neck
Eligibility Criteria
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
Sites / Locations
- Division of medical oncology, department of medicine Siriraj Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
prophylactic percutaneous gastrostomy
Arm 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 with nutrition counselling
Outcomes
Primary Outcome Measures
treatment interruption due to toxicity
Secondary Outcome Measures
quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01876693
Brief Title
A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy
Official Title
A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy in Medical Practice
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
slow accrual in experiment arm
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell of Head and Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
nutrition counselling with nasogastric tube insertion in the cases of weight loss more than 10% or severe mucositis developed during chemoradiotherapy
Arm Title
prophylactic percutaneous gastrostomy
Arm Type
Experimental
Arm Description
prophylactic percutaneous gastrostomy with nutrition counselling
Intervention Type
Procedure
Intervention Name(s)
prophylactic percutaneous gastrostomy
Intervention Description
prophylactic percutaneous gastrostomy with nutrition counselling
Primary Outcome Measure Information:
Title
treatment interruption due to toxicity
Time Frame
during period of chemoradiatherapy, an expected average of 6 weeks
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
during period of chemoradiation, an expected avearage of 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suthinee Ithimakin, MD
Organizational Affiliation
Faculty of Medicine Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of medical oncology, department of medicine Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27028666
Citation
Pramyothin P, Manyanont S, Trakarnsanga A, Petsuksiri J, Ithimakin S. A prospective study comparing prophylactic gastrostomy to nutritional counselling with a therapeutic feeding tube if required in head and neck cancer patients undergoing chemoradiotherapy in Thai real-world practice. J Hum Nutr Diet. 2016 Dec;29(6):768-776. doi: 10.1111/jhn.12377. Epub 2016 Mar 29.
Results Reference
derived
Learn more about this trial
A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy
We'll reach out to this number within 24 hrs