Double-blinded, placebo-controlled trial on intravenous L-alanyl-L-glutamine in the incidence of oral mucositis following chemoradiotherapy in patients with head-and-neck cancer

Journal Article · Tue Aug 01 04:00:00 EDT 2006 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2006.03.042· OSTI ID:20850011

Cerchietti, Leandro C.A. ^[1]; Navigante, Alfredo H ^[1]; Lutteral, Maribel A ^[2]; Castro, Monica A ^[1]; Kirchuk, Ricardo ^[2]; Bonomi, Marcelo ^[1]; Cabalar, Maria Esther ^[2]; Roth, Berta ^[3]; Negretti, Graciela ^[4]; Sheinker, Beatriz ^[4]; Uchima, Patricia ^[4]

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1. Translational Research Unit, Instituto de Oncologia Angel H. Roffo, Universidad de Buenos Aires, Buenos Aires (Argentina)
2. Internal Medicine Department, Instituto de Oncologia Angel H. Roffo, Universidad de Buenos Aires, Buenos Aires (Argentina)
3. Radiotherapy Department, Instituto de Oncologia Angel H. Roffo, Universidad de Buenos Aires, Buenos Aires (Argentina)
4. Pharmacy Department, Instituto de Oncologia Angel H. Roffo, Universidad de Buenos Aires, Buenos Aires (Argentina)

Purpose: We performed this double-blinded, placebo-controlled study to determine the safety and efficacy of L-alanyl-L-glutamine in the prevention of mucositis in patients with head-and-neck cancer. Methods and Materials: Thirty-two patients with head-and-neck cancer were treated with chemoradiotherapy (CRT) (radiotherapy daily up to 70 Gy plus cisplatin/5-fluoruracil once a week) and were asked to participate. Twenty-nine patients received the CRT schedule and were double-blindly assigned to receive either intravenous L-alanyl-L-glutamine 0.4 g/kg weight/day or an equal volume of saline (placebo) during chemotherapy days. Results: Fourteen patients received L-alanyl-L-glutamine and 15 received placebo. Mucositis was assessed by the Objective Mucositis Score (OMS) and the World Health Organization (WHO) grading system. There was a significant difference in incidence of mucositis developed in patients receiving placebo compared with those who received L-alanyl-L-glutamine (p = 0.035). The number of patients with severe objective mucositis (OMS >1.49) was higher in the placebo group compared with the L-alanyl-L-glutamine group (67% vs. 14%, p 0.007). L-alanyl-L-glutamine patients experienced less pain (three highest Numeric Rating Scale scores of 1.3/10 vs. 6.3/10 respectively, p = 0.008) and need for feeding tubes (14% vs. 60% respectively, p = 0.020) compared with placebo patients. No adverse effects related to the drug or the infusions were noted in either group. Conclusion: For patients with head-and-neck cancer receiving CRT, intravenous L-alanyl-L-glutamine may be an effective preventive measure to decrease the severity of mucositis.

• OSTI ID: 20850011
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 5 Vol. 65; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
CHEMOTHERAPY
COMBINED THERAPY
DRUGS
GLUTAMINE
HEAD
INFUSION
NECK
NEOPLASMS
PAIN
PATIENTS
RADIOTHERAPY