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.

Double-blind randomized study of oral glutamine on the management of radio/chemotherapy-induced mucositis and dermatitis in head and neck cancer

“…The conclusions of this meta-analysis revealed that glutamine significantly reduced the risk and severity of oral mucositis induced by RT or CHRT compared with either placebo or no treatment (risk ratio 0.17; 95% CI 0.06-0.47) (21)(22)(23)(24)(25). Another systematic review of well-designed studies in various solid tumors and patients with hematological cancer revealed inadequate or conflicting evidence (26), as five studies did not find glutamine to be effective (27)(28)(29)(30), while four studies did (19,(31)(32)(33), suggesting a requirement for further studies on the use of oral glutamine to guide clinicians on which interventions are truly effective.…”

Symposium 4: Hot topics in parenteral nutrition A review of the use of glutamine supplementation in the nutritional support of patients undergoing bone-marrow transplantation and traditional cancer therapy

“…Three studies report reduced mucositis with glutamine (11)(12)(13) , while two report reduced subjective measures of mucositis (gut absorbtive capacity and endoscopic appearances) but no reduction in subjective symptoms of mucositis (14,15) . Three studies report no change in mucositis (16,17,19) . Neither of the two studies reporting infections (12,19) demonstrates a difference in the number of infections.…”

“…There is also a reduction in infections with intravenous glutamine. There is, however, an increase in relapse with intravenous Objective Cerchietti et al (12) Daniele et al (13) Huang et al (15) Jebb et al (16) Okuno et al (17) Peterson et al (18) Subtotal (95 % CI) Total events Heterogeneity: χ 2 5.24, df 4 (P=0·26); I 2 24 % Test for overall effect: Z 1·07 (P=0·28) Subjective Huang et al (15) Okuno et al (17) Subtotal (95 % CI) Total events Heterogeneity: χ 2 0·00, df 1 (P=1·00); I 2 0 % Test for overall effect: Z 0·45 (P=0·65) Objective Huang et al (15) Jebb et al (16) Okuno et al (17) Peterson et al (18) Subtotal ( glutamine but this result was based on two small studies (30,32) of patients undergoing autologous transplantation.…”

Dietary Supplement Use in Cancer Care: Help or Harm

“…However, despite the previous positive trials, a large phase III trial testing oral glutamine with 5-fluorouracil (5-FU) chemotherapy did not show benefit [120]. One hundred and thirty four subjects, randomized to receive 4 g of glutamine twice a day, were instructed to retain the glutamine mouthwash in their mouths for only 10 seconds.…”