Rice bran arabinoxylan compound and quality of life of cancer patients (RBAC – QoL): Study protocol for a randomized pilot feasibility trial

Introduction : Rice bran arabinoxylan com pound (RBAC) is a nutraceutical for enhancing a depleted immune system during and after cancer treatment. This pilot feasibility trial aims to evaluate the effects of RBAC on cancer patients’ quality of life during active treatment, compared to placebo, using a validated questionnaire. Other outcome measures include changes in inflammatory and nutritional status, cytokine pro file, and gut mi – crobiota. Methods/ Design : The study will recruit 50 participants from a regional cancer center in Australia. Patients aged 18 –70, diagnosed with solid or an cancers stage II and above, and currently undergoing active systemic thera – pies, are eligible. Random allocation of participants into two groups is stratified based on metastatic status and treatment type. The dosage is either 3 g/ day of RBAC or placebo in identical packaging. The participants, study coordinator, and treating oncologists are blinded to the interventions. Data collections are at base line and at four follow – up sessions, which are six weeks apart (24 weeks). Statistical analysis will in volve a pro – tected p – value with multiple dependent values and analyzed by ANOVA with repeated measures on the occa – sion of testing and with both a full Bonferroni or Sidak corrections applied to protect against Type I errors. Any observed significance war rants further analysis with pair wise comparisons. Analysis of covariance will also be performed to assess any in fluence of the demographic data, cancer diagnosis, as well as changes in physical activity, dietary habits, and complementary medicine usage. Comparisons of gut microbiota will be based on the analysis of the fecal microbiome using 16S ribosomal ribonucleic acid amplicon sequencing. The proposed research time line is from October 2018 to May 2022. Trial registration : ANZCTR. Reg No: AC TRN12619000562178p.