TY - JOUR
T1 - Phase III controlled evaluation of glutamine for decreasing stomatitis in patients receiving fluorouracil (5-FU)-based chemotherapy
AU - Okuno, Scott H.
AU - Woodhouse, Charles O.
AU - Loprinzi, Charles L.
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
U2 - 10.1097/00000421-199906000-00009
DO - 10.1097/00000421-199906000-00009
M3 - Article
C2 - 10362332
AN - SCOPUS:0033512244
SN - 0277-3732
VL - 22
SP - 258
EP - 261
JO - American Journal of Clinical Oncology: Cancer Clinical Trials
JF - American Journal of Clinical Oncology: Cancer Clinical Trials
IS - 3
ER -