Clinical trial NCT03015077: Effects of Oral L-Glutamine in Head and Neck Cancer Patients During Radiotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Glutamine
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 59
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Histopathological diagnosis of malignant head and neck tumor.
* able to open his or her mouth wider than the width of one finger during the assessment of oral mucositis.
* Eastern Cooperative Oncology Group（ECOG）0-2
* complete radiotherapy (six to seven weeks with targets involving oral cavity or oropharynx)

Exclusion Criteria:

* History of previous radiotherapy.
* diabetes or nephritic or hepatic problems.
* serious infection or sepsis.
* distant metastases

Primary outcomes:
measure: grade of oral mucositis
timeFrame: once a week during radiotherapy and once after radiotherapy up to 8 weeks
measure: grade of neck dermatitis
timeFrame: once a week during radiotherapy and once after radiotherapy up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsihung Medical University Hospital
Study officials:
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