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Effects of Oral L-Glutamine in Head and Neck Cancer Patients During Radiotherapy

NCT03015077 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2017-01-10

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

oral glutamine

L-Glutamine and maltodextrin are both nutritional supplements. In the glutamine arm: 10 g L-Glutamine and 5 g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.

DIETARY_SUPPLEMENT

placebo

in the placebo arm: 15 g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.

RADIATION

Radiotherapy

All patients undergo radiotherapy. 5 days a week. All patients had a dental evaluation for good oral hygiene prior to computed tomography simulation for radiotherapy. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. The course of radiation was initiated no more than 6 weeks after resection. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions.

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03015077 on ClinicalTrials.gov