A Randomized, Double-Blind Pilot Trial of Hydrolyzed Rice Bran versus Placebo for Radioprotective Effect on Acute Gastroenteritis Secondary to Chemoradiotherapy in Patients with Cervical Cancer

Yoshiyuki Itoh, Mika Mizuno, Mitsuru Ikeda, Rie Nakahara, Seiji Kubota, Junji Ito, Tohru Okada, Mariko Kawamura, Fumitaka Kikkawa, Shinji Naganawa, Yoshiyuki Itoh, Mika Mizuno, Mitsuru Ikeda, Rie Nakahara, Seiji Kubota, Junji Ito, Tohru Okada, Mariko Kawamura, Fumitaka Kikkawa, Shinji Naganawa

Abstract

We aimed to evaluate the radioprotective effect of hydrolyzed rice bran (HRB) on acute gastroenteritis due to chemoradiotherapy for treatment of cervical cancer. This placebo-controlled, double-blind study was conducted as an exploratory investigation of the colitis-inhibiting effects of HRB in alleviating acute-phase gastrointestinal side effects of chemoradiotherapy. The study involved 20 patients (10 in the HRB group, 10 in the control group). The patients in the control group underwent the same chemoradiotherapy regimen as those in the HRB group, but they received a placebo instead of HRB. The diarrheal side effect assessment score was lower in the HRB than control group, and a trend toward a reduction in diarrhea symptoms was observed with the oral intake of HRB. Additionally, no significant difference was observed in the administration of intestinal regulators and antidiarrheal agents, but again the assessment score was lower in the HRB than control group, and diarrhea symptoms were alleviated with the oral intake of HRB. A trend toward no need for strong antidiarrheal agents was seen. Although this study was an exploratory clinical trial, the results suggest that HRB may relieve diarrhea, an acute-phase gastrointestinal side effect of chemoradiotherapy.

Figures

Figure 1
Figure 1
(a) Effects of HRB on diarrhea after chemoradiotherapy. (b) Effects of HRB on use of antidiarrheal agents after chemoradiotherapy. (c) Effects of HRB on nausea after chemoradiotherapy.
Figure 2
Figure 2
NK cell activity before and after chemoradiotherapy.

References

    1. Keys H. M., Bundy B. N., Stehman F. B., et al. Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. The New England Journal of Medicine. 1999;340(15):1154–1161. doi: 10.1056/nejm199904153401503.
    1. Morris M., Eifel P. J., Lu J., et al. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. The New England Journal of Medicine. 1999;340(15):1137–1143. doi: 10.1056/nejm199904153401501.
    1. Rose P. G., Bundy B. N., Watkins E. B., et al. Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. The New England Journal of Medicine. 1999;340(15):1144–1153. doi: 10.1056/nejm199904153401502.
    1. Green J. A., Kirwan J. M., Tierney J. F., et al. Survival and recurrence after concomitant chemotherapy and radiotherapy for cancer of the uterine cervix: a systematic review and meta-analysis. The Lancet. 2001;358(9284):781–786. doi: 10.1016/s0140-6736(01)05965-7.
    1. Portelance L., Chao K. S. C. C., Grigsby P. W., Bennet H., Low D. Intensity-modulated radiation therapy (IMRT) reduces small bowel, rectum, and bladder doses in patients with cervical cancer receiving pelvic and para-aortic irradiation. International Journal of Radiation Oncology Biology Physics. 2001;51(1):261–266. doi: 10.1016/s0360-3016(01)01664-9.
    1. Kirwan J. M., Symonds P., Green J. A., Tierney J., Collingwood M., Williams C. J. A systematic review of acute and late toxicity of concomitant chemoradiation for cervical cancer. Radiotherapy and Oncology. 2003;68(3):217–226. doi: 10.1016/s0167-8140(03)00197-x.
    1. Mundt A. J., Lujan A. E., Rotmensch J., et al. Intensity-modulated whole pelvic radiotherapy in women with gynecologic malignancies. International Journal of Radiation Oncology Biology Physics. 2002;52(5):1330–1337. doi: 10.1016/S0360-3016(01)02785-7.
    1. Benson A. B., III, Ajani J. A., Catalano R. B., et al. Recommended guidelines for the treatment of cancer treatment-induced diarrhea. Journal of Clinical Oncology. 2004;22(14):2918–2926. doi: 10.1200/jco.2004.04.132.
    1. Gibson R. J., Keefe D. M. K., Lalla E. B., et al. For the mucositis study group of the multinational association of supportive care in cancer/international society of oral oncology (MASCC/ISOO). Systemic review of agents for the management of gastrointesitinal mucositis in cancer patients. Support Care in Cancer. 2013;21:313–326. doi: 10.1007/s00520-012-1644-z.
    1. Hoshino Y., Hirashima N., Nakanishi M., Furuno T. Inhibition of degranulation and cytokine production in bone marrow-derived mast cells by hydrolyzed rice bran. Inflammation Research. 2010;59(8):615–625. doi: 10.1007/s00011-010-0173-9.
    1. Tazawa K., Ichihashi K., Fujie T., Omura K., Anazawa M., Maeda H. The orally administration of the hydrolysis rice bran prevents a common cold syndrome for the elderly people based on immnunomodulatory function. Journal of Traditional Medicines. 2003;20:132–141.
    1. Ghoneum M., Abedi S. Enhancement of natural killer cell activity of aged mice by modified arabinoxylan rice bran (MGN-3/Biobran) Journal of Pharmacy and Pharmacology. 2004;56(12):1581–1588. doi: 10.1211/0022357044922.
    1. Thornthwaite J. T., Shah H., Shah P., Respess H. The natural killer cell: a historical perspective and the use of supplements to enhance NKC activity. Journal of Immune Based Therapies, Vaccines and Antimicrobials. 2012;1(3):21–51. doi: 10.4236/jibtva.2012.13004.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅