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Phase III controlled evaluation of glutamine for decreasing stomatitis in patients receiving fluorouracil (5-FU)-based chemotherapy.
Am J Clin Oncol 1999; 22(3):258-61AJ

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+Show Affiliations

Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

10362332

Citation

Okuno, S H., et al. "Phase III Controlled Evaluation of Glutamine for Decreasing Stomatitis in Patients Receiving Fluorouracil (5-FU)-based Chemotherapy." American Journal of Clinical Oncology, vol. 22, no. 3, 1999, pp. 258-61.
Okuno SH, Woodhouse CO, Loprinzi CL, et al. Phase III controlled evaluation of glutamine for decreasing stomatitis in patients receiving fluorouracil (5-FU)-based chemotherapy. Am J Clin Oncol. 1999;22(3):258-61.
Okuno, S. H., Woodhouse, C. O., Loprinzi, C. L., Sloan, J. A., LaVasseur, B. I., Clemens-Schutjer, D., ... Pierson, N. (1999). Phase III controlled evaluation of glutamine for decreasing stomatitis in patients receiving fluorouracil (5-FU)-based chemotherapy. American Journal of Clinical Oncology, 22(3), pp. 258-61.
Okuno SH, et al. Phase III Controlled Evaluation of Glutamine for Decreasing Stomatitis in Patients Receiving Fluorouracil (5-FU)-based Chemotherapy. Am J Clin Oncol. 1999;22(3):258-61. PubMed PMID: 10362332.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase III controlled evaluation of glutamine for decreasing stomatitis in patients receiving fluorouracil (5-FU)-based chemotherapy. AU - Okuno,S H, AU - Woodhouse,C O, AU - Loprinzi,C L, AU - Sloan,J A, AU - LaVasseur,B I, AU - Clemens-Schutjer,D, AU - Swan,D, AU - Axvig,C, AU - Ebbert,L P, AU - Tirona,M R, AU - Michalak,J C, AU - Pierson,N, PY - 1999/6/11/pubmed PY - 1999/6/11/medline PY - 1999/6/11/entrez SP - 258 EP - 61 JF - American journal of clinical oncology JO - Am. J. Clin. Oncol. VL - 22 IS - 3 N2 - 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. SN - 0277-3732 UR - https://www.unboundmedicine.com/medline/citation/10362332/Phase_III_controlled_evaluation_of_glutamine_for_decreasing_stomatitis_in_patients_receiving_fluorouracil__5_FU__based_chemotherapy_ L2 - http://dx.doi.org/10.1097/00000421-199906000-00009 DB - PRIME DP - Unbound Medicine ER -