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

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.

Urgent Necessity for Standardized and Evidence Based Plant Immunomodulators (Such As Rice Bran Arabinoxylan Concentrate/MGN-3) for the Tumor Research

“…We need in term of PAMP like molecules standardized, immunological and clinical evidence based plant immunomodulators. The first plant immunomodulator which can correspond to these requirements is a standardized Rice Bran Arabinoxylan Concentrate (BioBran/ MGN-3) which also as food supplement is registered in spite of the immunological and clinical (based on randomized double blind trial) evidences [8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]. Unfortunately, oncological centers are not ready to carry out further investigations with food supplements and arabinoxylan concentrate can't take part on further controlled clinical trials.…”

Can a standardized plant immunomodulator (rice bran arabinoxylan concentrate/MGN-3) increase the effects of MEK and BRAF inhibitors with clinical benefit? Case report of a patient with carcinoma in biliary duct

“…Unfortunately, the best evidence based and standardized immunodulators without any side effects are plant extracts and they are all over the world registered only as food supplements. There are growing evidences that plant PAMP-like molecules (such as standardized rice bran arabinoxylan concentrate) exhibit a lot of immunological [15][16][17][18][19][20][21][22][23][24][25][26] and clinical benefit [27][28][29]. Therefore, further clinical trials are necessary to investigate this beneficial interaction.…”

Nutritional strategies to prevent gastrointestinal toxicity during pelvic radiotherapy

“…Eight studies (57)(58)(59)(60)(61)(62)(63)(64)(65) recruiting 639 patients, comprising six RCT (57,59,(61)(62)(63)(64)(65) (including one cross-over trial (57) ) and two cohort studies (58,60) have explored the benefit of manipulating dietary and/or supplemental fibre during pelvic irradiation. Of the interventional RCT, two manipulated dietary fibre alone (60,65) , three used a fibre supplement (59,63,64) (two of which included additional dietary restrictions (59,64) ) and a further study with long-term follow-up manipulated dietary fibre in combination with a low-lactose restriction (61,62) . Seven studies (58)(59)(60)(61)(62)(63)(64)(65) explored the role of fibre in preventing gastrointestinal toxicity (i.e.…”

“…Of the interventional RCT, two manipulated dietary fibre alone (60,65) , three used a fibre supplement (59,63,64) (two of which included additional dietary restrictions (59,64) ) and a further study with long-term follow-up manipulated dietary fibre in combination with a low-lactose restriction (61,62) . Seven studies (58)(59)(60)(61)(62)(63)(64)(65) explored the role of fibre in preventing gastrointestinal toxicity (i.e. as a prophylactic agent) whilst one (57) explored the therapeutic efficacy of the psyllium v. codeine phosphate for the control of radiation-induced diarrhoea.…”

“…There is moderately convincing evidence that increasing, rather than reducing fibre intake during pelvic radiotherapy has beneficial effects. Two studies using dietary manipulation (60,65) and three (59,63,64) using supplements reported improved bowel symptom scores (60,65) and improvements in stool consistency and diarrhoea outcomes (59,63,64) compared with low-fibre or non-supplemented groups. In contrast, in two studies using low-fibre dietary interventions, one reported no difference in gastrointestinal symptom scores between intervention and standard care groups either during or in the post-treatment setting (61,62) whilst a further study (58) reported improved genitourinary and gastrointestinal symptoms in patients compliant with low-fibre dietary advice amongst a number of other dietary restrictions.…”