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

NCT03015077 | Completed DMC

• 1 other identifier: KMUHIRB-2014-12-01(II)
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Glutamine

Outcome Measures

Primary Outcomes (2)

• grade of oral mucositis

  Oral mucositis and radiation-induced dermatological toxicity were evaluated during and after treatment using the National Cancer Institute Common Toxicity Criteria version 3.0 (CTCAE v.3). The scoring was done as the patients went through the treatment by the attending physicians. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions.

  once a week during radiotherapy and once after radiotherapy up to 8 weeks

• grade of neck dermatitis

  Oral mucositis and radiation-induced dermatological toxicity were evaluated during and after treatment using the National Cancer Institute Common Toxicity Criteria version 3.0 (CTCAE v.3). The scoring was done as the patients went through the treatment by the attending physicians. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions.

  once a week during radiotherapy and once after radiotherapy up to 8 weeks

Study Arms (2)

Glutamine

ACTIVE COMPARATOR

intake of 5g glutamine and 10g maltodextrin. Oral glutamine is a food additive issued by food and drug government in Taiwan with number 009929.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: oral glutamine; Radiation: Radiotherapy

placebo

PLACEBO COMPARATOR

intake of 15g 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; Radiation: Radiotherapy

Interventions

oral glutamine DIETARY_SUPPLEMENT

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.

Glutamine

placebo DIETARY_SUPPLEMENT

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.

placebo

Radiotherapy RADIATION

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.

Glutamine; placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsihung Medical University Hospital

Kaohsiung City, 80708, Taiwan

Location

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MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Glutamine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2016
• First Posted: January 9, 2017
• Study Start: July 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 10, 2017

Record last verified: 2015-02

Locations

TW (1)