Double-blind placebo-controlled multicenter phase II trial to evaluate D-methionine in preventing/reducing oral mucositis induced by radiation and chemotherapy for head and neck cancer
| Autor: | Sudhir Borgonha, Avraham Eisbruch, Kuei C. Lee, Babu Phillip, Prasad S. Sunkara, Brian D. Ross, Alnawaz Rehemtulla, Kathleen C. M. Campbell, Daniel A. Hamstra |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Male medicine.medical_specialty Erythema medicine.medical_treatment Administration Oral Antineoplastic Agents Placebo Gastroenterology 03 medical and health sciences 0302 clinical medicine Methionine Double-Blind Method Internal medicine medicine Clinical endpoint Mucositis Humans Chemotherapy Stomatitis business.industry Head and neck cancer Middle Aged medicine.disease Clinical trial 030104 developmental biology Otorhinolaryngology Chemotherapy Adjuvant Head and Neck Neoplasms 030220 oncology & carcinogenesis Carcinoma Squamous Cell Female Radiotherapy Adjuvant medicine.symptom Cisplatin business Chemoradiotherapy |
| Zdroj: | Headneck. 40(7) |
| ISSN: | 1097-0347 |
| Popis: | Background The purpose of this study was to test if oral D-methionine (D-met) reduced mucositis during chemoradiotherapy. Methods We conducted a placebo-controlled double-blind randomized phase II trial of D-met (100 mg/kg p.o. b.i.d.) testing the rate of severe (grades 3-4) mucositis. Results Sixty patients were randomized. Grade 2 + oral pain was higher with placebo (79% vs 45%; P = .0165), whereas grade 2 + body odor was greater with D-met (3% vs 41%; P = .0015). Mucositis was decreased with D-met by the physician (World Health Organization [WHO], P = .007; Radiation Therapy Oncology Group [RTOG], P = .009) and patient functional scales (RTOG, P = .0023). The primary end point of grades 3 to 4 mucositis on the composite scale demonstrated a decrease with D-met (48% vs 24%; P = .058), which was borderline in significance. A planned secondary analysis of a semiquantitative scoring system noted decreased oral ulceration (2.2 vs 1.5; P = .023) and erythema (1.6 vs 1.1; P = .048) with D-met. Conclusion Although not meeting the primary end point, results of multiple assessments suggest that D-met decreased mucositis. |
| Databáze: | OpenAIRE |
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