Study Stopped
slow accrual in experiment arm
A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy
1 other identifier
interventional
95
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 21, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMarch 31, 2016
March 1, 2016
1.8 years
May 21, 2013
March 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
treatment interruption due to toxicity
during period of chemoradiatherapy, an expected average of 6 weeks
Secondary Outcomes (1)
quality of life
during period of chemoradiation, an expected avearage of 6 weeks
Study Arms (2)
control
NO INTERVENTIONnutrition counselling with nasogastric tube insertion in the cases of weight loss more than 10% or severe mucositis developed during chemoradiotherapy
prophylactic percutaneous gastrostomy
EXPERIMENTALprophylactic percutaneous gastrostomy with nutrition counselling
Interventions
prophylactic percutaneous gastrostomy with nutrition counselling
Eligibility Criteria
You may qualify if:
- pathologically confirmed of head and neck cancer
- plan to have chemoradiotherapy session
- Performance status of 0-2
You may not qualify if:
- contraindications for percutaneous gastrostomy, eg coagulopathy, obstructed tumor
- Body mass index less than 16 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of medical oncology, department of medicine Siriraj Hospital
Bangkok, 10700, Thailand
Related Publications (1)
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.
PMID: 27028666DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suthinee Ithimakin, MD
Siriraj Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
May 21, 2013
First Posted
June 12, 2013
Study Start
May 1, 2013
Primary Completion
February 1, 2015
Study Completion
June 1, 2015
Last Updated
March 31, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share