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


N/A
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Squamous Cell of Head and Neck

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

treatment interruption due to toxicity

Outcome Time Frame:

during period of chemoradiatherapy, an expected average of 6 weeks

Safety Issue:

No

Principal Investigator

Suthinee Ithimakin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Faculty of medicine Siriraj Hospital

Authority:

Thailand: Ethical Committee

Study ID:

si041/2013

NCT ID:

NCT01876693

Start Date:

May 2013

Completion Date:

September 2015

Related Keywords:

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

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