title: Phase III controlled evaluation of glutamine for decreasing stomatitis in patients receiving fluorouracil (5-FU)-based chemotherapy.
abstract: Mucositis is a prominent dose-limiting toxicity associated with 5-FU-based chemotherapy. On the basis of preliminary data suggesting that the amino acid glutamine could alleviate this problem, the authors developed this trial. Patients scheduled to receive their first 5-FU-based chemotherapy regimen were selected for study. Following stratification, patients were randomized, in a double-blind manner, to receive oral glutamine or a placebo preparation in a prophylactic manner. Patients in both groups were given oral cryotherapy before chemotherapy and were evaluated for mucositis by standard physicians' evaluation and by a self-report instrument. Sixty-six patients were randomized to receive glutamine and 68 to receive the placebo preparation. There were no significant differences or substantial trends in the mucositis scores between the two study arms as measured by either the physicians or the patients. It was concluded that the dose and schedule of glutamine used in this clinical trial does not alleviate 5-FU-induced mucositis.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA.
authors.forename: S H
authors.initials: SH
authors.lastname: Okuno
authors.forename: C O
authors.initials: CO
authors.lastname: Woodhouse
authors.forename: C L
authors.initials: CL
authors.lastname: Loprinzi
authors.forename: J A
authors.initials: JA
authors.lastname: Sloan
authors.forename: B I
authors.initials: BI
authors.lastname: LaVasseur
authors.forename: D
authors.initials: D
authors.lastname: Clemens-Schutjer
authors.forename: D
authors.initials: D
authors.lastname: Swan
authors.forename: C
authors.initials: C
authors.lastname: Axvig
authors.forename: L P
authors.initials: LP
authors.lastname: Ebbert
authors.forename: M R
authors.initials: MR
authors.lastname: Tirona
authors.forename: J C
authors.initials: JC
authors.lastname: Michalak
authors.forename: N
authors.initials: N
authors.lastname: Pierson
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects*; D005973:Glutamine / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes; D013280:Stomatitis / Q000139:chemically induced* / Q000517:prevention & control*
chemical_list: D000964:Antimetabolites, Antineoplastic; D009067:Mouthwashes; D005973:Glutamine; D005472:Fluorouracil