Head and Neck Cancer Clinical Trial
Official title:
Impacts of Oral Supplement With L-Glutamine on the Radiation-induced Toxicity and Nutritional Status of Head and Neck Cancer Patients Under Radiotherapy
The rapidly increasing mortality and incidence of oral cancer has become a public health
major problem in Taiwan. To date, the treatment of head and neck cancer mainly include
surgery, radiotherapy and chemotherapy. However, radiotherapy and chemotherapy might have an
influence on the patients' diet by causing dismal side effects, including nausea, vomiting,
pain, infection, dysorexia, allotriogeustia, oral ulceration and dysphagia, which make the
patients more difficult to absorb nutrients. In the previous study, the incidence of
malnutrition among the patients with cancer has been estimated at between 40 and 80%,
especially occurred in the patients with head and neck cancers and upper gastrointestinal
cancers.
In this study, the effect of supplement with L-Glutamine on the nutritional status and
radiation-induced toxicity of head and neck cancer patients will be evaluated to improve the
patients' quality of life when they are undergoing radiotherapy. When the head and neck
cancer patients undergoing radiotherapy, patients' instructions and nutrient intervention of
L-Glutamine are performed to maintain the patients' nutritional status and reduce the
patients' diet-related or other side effects caused by radiotherapy. It is anticipated that
head and neck cancer patients with surgery and radiotherapy intake with L-Glutamine might
decrease treatment-related side effects and hence improve their quality of life when they
are undergoing radiotherapy.
1. Written informed consent must be obtained before any study specific procedures are
undertaken.
2. The process of the experiment A. head and neck cancer patients with surgery and
radiotherapy are identified in clinic at the Department of Dentistry and the Department
of Radiotherapy in Kaohsiung Medical University Chung-Ho Memorial Hospital.
B. Inform these patients about the value of this clinical trial in detail, and make sure
that they understand all the meanings of each procedure in this clinical trial.
Subsequently, the patients who are willing to participate in this study are enrolled after
completing institutionally approved informed consent.
C. In order to assess the effect of supplement with L-Glutamine on the nutritional status
and diet of head and neck cancer patients with surgery and radiotherapy, the enrolled
patients will be divided into two groups randomly. One group is supplied with 10 g
L-Glutamine and 5 g maltodextrin; the other group is supplied with 15 g maltodextrin as
control group. The patients of these two groups take their supplemental nutrients three
times a day, respectively, in a period of time of 7 days before radiotherapy to 14 days
after radiotherapy.
D. Meanwhile, the research assistants will monitor the patients' condition carefully by
recording their daily diet, nutritional status and side effects caused by radiotherapy at
three specific time-points during the whole clinic trial program course.
E. The monitor items of patients' nutritional status include the daily diet of patients
before and after radiotherapy by recording 24 hr recall table and food frequency table,(b)
the physical examination of height, weight, ideal weight, tricept skinfold (TSF), mid-arm
circumference (MAC) and mid-arm muscle circumference (MAMC), (d) prognostic nutritional
index (PNI), (e) biochemistry inspection assessment and (g) complete blood count (CBC).
F. The monitor items of patients' diet-related side effects caused by radiotherapy include
(a) oral mucositis and (b) neck dermatitis.
G. The above-mentioned monitor items will be recorded carefully by the research assistants
at three specific time-points during the whole clinic trial program course, which are
initial point (7 days before radiotherapy), medium point (medium date during radiotherapy)
and final point (14 days after radiotherapy).
H. The research assistants will help the patients make an appointment, and let them visit
the doctor on schedule. And make sure the patients actually follow up the suggestions and
obey the instructions during the clinic trial.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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