Itoh 2015.

Study characteristics
Methods	Design: Randomised, placebo‐controlled, double‐blind pilot trial. Country: Japan Accrual dates: NR Trial Reg.: NR Funding source: Daiwa Pharmaceutical Co., Ltd., the manufacturer of both the HRB and placebo foods, which were provided free of charge
Participants	No. randomised: 20 Inclusion criteria: Patients with primary squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma located in the cervix were included. (i) age of ≥ 20 to < 75 years at the time of providing informed consent; (ii) cervical cancer with the intent for chemoradiotherapy; (iii) adequately‐maintained major organ function (bone marrow, liver, and kidneys) and laboratory parameters within the following ranges: white blood cell count of > 3500/mm3, absolute neutrophil count of > 1500/mm3, haemoglobin A1c level of ≥ 10.0 g/dL, platelet count of ≥ 100,000/mm3, total bilirubin level of ≤ 1.5 mg/dL, AST and ALT levels of < 80 IU/L, serum creatinine level of < 1.5 mg/dL, and creatinine clearance rate of ≥ 60mL/min (Cockcro ‐Gault formula or 24‐hour creatinine clearance); and (iv) having received an explanation of the purpose and methods of this trial and having provided written consent prior to the start of the trial Exclusion criteria: Patients with small cell carcinoma or sarcoma were excluded. (i) undergoing surgical treatment; (ii) undergoing a nonsurgical treatment thought to affect treatment with HRB and its outcome; (iii) presence of a drug allergy; (iv) known or possible pregnancy, desire to become pregnant, or currently breastfeeding; and (v) other conditions that the principal investigator or a coresearcher thought might make an individual unsuitable for this study Gender: Female Age: Intervention: 47.5 (median) 30 ‐ 72 (range), Control: 47.5 (median) 30 ‐ 72 (range) Type of cancer: Cervical cancer: 18 squamous cell carcinoma and 2 adenosquamous carcinoma Radiotherapy regimen received: EBRT 50.4 Gy in standard fractionation and brachytheraphy Primary/adjuvant/other: Primary Other treatment received: Chemotherapy regimen was performed every 3 weeks: cisplatin at 70 mg/m2 on day 1 and a continuous infusion of 5‐FU at 700 mg/m2 on days 1 to 4
Interventions	Comparison: hydrolysed rice bran (HRB) vs placebo Arm 1: 3 packets of the HRB (1 g of HRB per packet) were taken orally 3 times a day. The HRB was consumed before the start of chemoradiotherapy (up to 1 week before) and it was taken every day while receiving RT. Use of each drug has been also stopped simultaneously with EBRT end. Arm 2: Identical‐looking placebo. 3 packets of the placebo food were taken orally 3 times a day
Outcomes	GI toxicity: Acute CTCAE v 3.0 QoL: NR Other review outcomes: NR Other study outcomes: Secondary end points were the frequency and severity of gastrointestinal symptoms other than diarrhoea (nausea, vomiting, and loss of appetite) and NK cell activity Duration of follow‐up: During RT
Notes	None
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient detail to make a judgement.
Allocation concealment (selection bias)	Unclear risk	Insufficient detail to make a judgement.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Low risk, authors state that participants were blinded to treatment group
Blinding of outcome assessment	Low risk	Low risk, authors state that participants' doctors were blinded to treatment group
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Recruited 20 but only analysed 14 due to exclusions, mainly based on non‐compliance due to chemo‐induced nausea and vomiting
Selective reporting (reporting bias)	High risk	Prespecified outcomes have been reported but the methodology of deriving the final scores (i.e. diarrhoeal side effect assessment score) is not provided
Other bias	High risk	Small non‐powered trial. Methodology for deriving primary end point unclear
Overall judgement	High risk	High risk overall