Phase III controlled evaluation of glutamine for decreasing stomatitis in patients receiving fluorouracil (5-FU)-based chemotherapy

Scott Heitaka Okuno, Charles O. Woodhouse, Charles Lawrence Loprinzi, Jeff A Sloan, Beth I. LaVasseur, Danette Clemens-Schutjer, Debra Swan, Claudia Axvig, Larry P. Ebbert, Maria R B Tria Tirona, John C. Michalak, Nancy Pierson

Research output: Contribution to journalArticle

60 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)258-261
Number of pages4
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume22
Issue number3
StatePublished - Jun 1999

Fingerprint

Stomatitis
Glutamine
Mucositis
Fluorouracil
Drug Therapy
Placebos
Physicians
Cryotherapy
Self Report
Appointments and Schedules
Clinical Trials
Amino Acids

Keywords

  • 5-FU chemotherapy
  • Mucositis
  • Placebo-controlled trial

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Phase III controlled evaluation of glutamine for decreasing stomatitis in patients receiving fluorouracil (5-FU)-based chemotherapy. / Okuno, Scott Heitaka; Woodhouse, Charles O.; Loprinzi, Charles Lawrence; Sloan, Jeff A; LaVasseur, Beth I.; Clemens-Schutjer, Danette; Swan, Debra; Axvig, Claudia; Ebbert, Larry P.; Tria Tirona, Maria R B; Michalak, John C.; Pierson, Nancy.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 22, No. 3, 06.1999, p. 258-261.

Research output: Contribution to journalArticle

Okuno, SH, Woodhouse, CO, Loprinzi, CL, Sloan, JA, LaVasseur, BI, Clemens-Schutjer, D, Swan, D, Axvig, C, Ebbert, LP, Tria Tirona, MRB, Michalak, JC & 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: Cancer Clinical Trials, vol. 22, no. 3, pp. 258-261.
Okuno, Scott Heitaka ; Woodhouse, Charles O. ; Loprinzi, Charles Lawrence ; Sloan, Jeff A ; LaVasseur, Beth I. ; Clemens-Schutjer, Danette ; Swan, Debra ; Axvig, Claudia ; Ebbert, Larry P. ; Tria Tirona, Maria R B ; Michalak, John C. ; Pierson, Nancy. / Phase III controlled evaluation of glutamine for decreasing stomatitis in patients receiving fluorouracil (5-FU)-based chemotherapy. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 1999 ; Vol. 22, No. 3. pp. 258-261.
@article{ff4796715198461497d551f475a1f391,
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.",
keywords = "5-FU chemotherapy, Mucositis, Placebo-controlled trial",
author = "Okuno, {Scott Heitaka} and Woodhouse, {Charles O.} and Loprinzi, {Charles Lawrence} and Sloan, {Jeff A} and LaVasseur, {Beth I.} and Danette Clemens-Schutjer and Debra Swan and Claudia Axvig and Ebbert, {Larry P.} and {Tria Tirona}, {Maria R B} and Michalak, {John C.} and Nancy Pierson",
year = "1999",
month = "6",
language = "English (US)",
volume = "22",
pages = "258--261",
journal = "American Journal of Clinical Oncology: Cancer Clinical Trials",
issn = "0277-3732",
publisher = "Lippincott Williams and Wilkins",
number = "3",

}

TY - JOUR

T1 - Phase III controlled evaluation of glutamine for decreasing stomatitis in patients receiving fluorouracil (5-FU)-based chemotherapy

AU - Okuno, Scott Heitaka

AU - Woodhouse, Charles O.

AU - Loprinzi, Charles Lawrence

AU - Sloan, Jeff A

AU - LaVasseur, Beth I.

AU - Clemens-Schutjer, Danette

AU - Swan, Debra

AU - Axvig, Claudia

AU - Ebbert, Larry P.

AU - Tria Tirona, Maria R B

AU - Michalak, John C.

AU - Pierson, Nancy

PY - 1999/6

Y1 - 1999/6

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.

AB - 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.

KW - 5-FU chemotherapy

KW - Mucositis

KW - Placebo-controlled trial

UR - http://www.scopus.com/inward/record.url?scp=0033512244&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0033512244&partnerID=8YFLogxK

M3 - Article

C2 - 10362332

AN - SCOPUS:0033512244

VL - 22

SP - 258

EP - 261

JO - American Journal of Clinical Oncology: Cancer Clinical Trials

JF - American Journal of Clinical Oncology: Cancer Clinical Trials

SN - 0277-3732

IS - 3

ER -