Safety and Efficacy of oral and parenteral glutamine supplementation in reducing chemotherapy induced toxicities in patients with breast cancer receiving chemotherapy: Results of interim analysis of a prospective, randomized, three arm, placebo-controlled study (NCT00772824).
Manoj Pandey, Kumar Gaurav, Seema Singh and R. K. Goel
World Journal of Surgical Research 2012, 1:4
Background: Side effects associated with use of chemotherapeutic agents in patients with cancer are well known. The role of glutamine supplementation in reducing or preventing chemotherapy induced adverse effects especially gastro-intestinal toxicity in cancer patients is controversial. This randomized controlled trial was carried out to evaluate the effect of glutamine supplementation on chemotherapeutic toxicity in breast cancer.
Patients and methods: 23 patients with breast cancer receiving 72 cycles of adjuvant or neoadjuvant CEF chemotherapy were assessed. These patients were randomized in three groups at the beginning of each cycle to receive either placebo (n=23), or enteral glutamine (n=25) 2g/Kg body weight in divided doses for 5 days or 20% parenteral glutamine (n=24) 50 ml injection (10 g) before the beginning of chemotherapy. Primary end-point was reduction in overall non-fatal side effects and reduction in multiorgan toxicity as assessed by the WHO criteria of grading toxicity associated with use of anticancer drugs.
Results: Glutamine supplementation was associated with significantly lower grades of gastro-intestinal side effects specially nausea, vomiting, diarrhea and mucositis as compared to placebo group (p<0.05). When oral and parenteral glutamine groups were compared both were found to be equally effective (p>0.05) although oral supplementation was more effective in reducing mucositis (p<0.05).
Conclusions: Results of the present study show that glutamine supplementation significantly reduces the GI toxicity and have a favorable safety profile. It is further suggested that a combination of oral and parenteral glutamine may be given together for enhancement of effect.