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Trial registered on ANZCTR


Registration number
ACTRN12619000562178
Ethics application status
Approved
Date submitted
5/04/2019
Date registered
10/04/2019
Date last updated
22/01/2020
Date data sharing statement initially provided
10/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Rice bran arabinoxylan compound and quality of life of cancer patients (RBAC-QoL)
Scientific title
RBAC-QoL: Rice bran arabinoxylan compound (RBAC) for the quality of life (QoL) of cancer patients - A randomised pilot feasibility trial
Secondary ID [1] 297895 0
None
Universal Trial Number (UTN)
U1111-1231-2238
Trial acronym
RBAC-QoL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 312276 0
Quality of life 312277 0
Condition category
Condition code
Alternative and Complementary Medicine 310825 310825 0 0
Other alternative and complementary medicine
Cancer 310826 310826 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an oral supplement of rice bran arabinoxylan compound (RBAC) powder packed in plastic sachets. The dosage is 3g per day for a duration of 24 weeks. Each RBAC sachet contains 1g of the active ingredient with excipients of microcrystalline cellulose (500mg), dextrin (200mg), corn starch (260mg), and tricalcium phosphate (40mg).

The participants will take two sachets in the morning and one sachet in the evening during or after meals. The participants are to thoroughly mix the contents of the sachets into half a glass (approximately 125 ml) of water and drink it right away. This mode of administration makes the dry powder easy to swallow.

To ensure adherence, the study coordinator will repeatedly provide instructions about taking supplement sachets including timing, storage, and what to do in the event of a missed dose during initial dispensing and every subsequent visit. The participants are to return unused sachets at each follow-up visit to be counted and recorded for compliance assessment. Participants will continue their active cancer treatment and medications as instructed by their treating oncologists. However, all concomitant medications used during the study will be recorded and updated at baseline and during each visit.
Intervention code [1] 314122 0
Other interventions
Comparator / control treatment
The control intervention is a matching placebo powder which contains no active ingredient. Each placebo sachet contains microcrystalline cellulose (250mg), dextrin (100mg), corn starch (1260mg), and tricalcium phosphate (20mg). The placebo sachet has a slight difference in the contents of excipients than the RBAC sachet to achieve acceptable melt in the mouth. It also contains an infinitesimal amount of caramel, which is for colour matching and as a binder.
Control group
Placebo

Outcomes
Primary outcome [1] 319665 0
Quality of Life; Metric/method of measurement: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [1] 319665 0
The primary timepoints are 0 (baseline), 42, 84, 126, and 168 days upon commencement of the intervention.
Secondary outcome [1] 369081 0
Body composition inclusive of body mass index (BMI); Metric/method of measurement: Kilogram and percentages accessed with a digital scale with body composition measurements (Tanita Body Composition Scale RD545 or equivalent) with BMI = (Bodyweight in kg )/ (Height in m)^2.
Timepoint [1] 369081 0
The secondary timepoints are 0, 42, 84, 126, 168 days upon commencement.
Secondary outcome [2] 369082 0
Immune parameters (Human Cytokine Array / Chemokine Array 42-Plex) Metric/method of measurement: pg/ml. A total of 42 cytokine/chemokine parameters are measured from serum using the addressable laser bead immunoassay technology. These parameters are exploratory in nature to identify and understand the immunomodulating effects of RBAC on the quantity and activities of the various cytokines important in cancer.
Timepoint [2] 369082 0
The secondary timepoints are 0, 42, 84, 126, 168 days upon commencement.
Secondary outcome [3] 379017 0
Gut microbiome assessed with stool sample: Comparisons of diversity (alpha diversity) and composition of different gut bacteria groups (beta diversity).
Timepoint [3] 379017 0
The secondary timepoints are 0, 42, 84, 126, 168 days upon commencement.
Secondary outcome [4] 379018 0
Inflammatory-nutritional index (INI); Metric/method of measurement: INI = the ratio of C-Reactive Protein and albumin.
Timepoint [4] 379018 0
0, 42, 84, 126, 168 days upon commencement.
Secondary outcome [5] 379019 0
neutrophil to lymphocyte ratio (NLR)
Timepoint [5] 379019 0
0, 42, 84, 126, 168 days upon commencement.

Eligibility
Key inclusion criteria
Adult patient with informed consent, diagnosed with Stage II-IV solid organ cancers, maintains adequate major organ function (bone marrow, liver, and kidneys), currently undergoing active systemic therapies.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Existing mental health conditions that may impede the ability in providing consent; Inability to complete QoL questionnaire with minimal assistance; Pregnant, lactating, or has plan to get pregnant during the period of the trial; Active or prior documented autoimmune or inflammatory disorders within the last five years, except for vitiligo or alopecia, stable hypothyroidism on hormone replacement, and any chronic skin condition that does not require systemic therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with stratification based on metastatic or non-metastatic status using a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We have selected a sample size of 50, with 25 in each group. The choice is based on the recommendation that for a main trial designed with 90% power, two-sided 5% significance, and small standardised effect size (0.2), the pilot trial's sample size per intervention arm is 25 (Whitehead, Julious, Cooper & Campbell, 2016). This sample size of 50 also represents a practical choice since the study site is a regional cancer centre with a limited number of cancer patients.

Statistical analysis of the collected results will be conducted using R version 3.4.0 or later. We will compare the RBAC group against the placebo group in all primary and secondary outcomes analysis. Missing data will be handled based on the Last Observation Carried Forward approach. A protected P-value with multiple dependent values will be analysed by ANOVA with repeated measures on the occasions of testing with a full Bonferroni correction. We will perform pairwise comparisons with any observed significance. The significance threshold level is set at P< 0.05. Analysis of covariance will also be performed to assess any influence of the demographic data (age, gender, ethnicity) and cancer diagnosis (primary cancer type, stage of the disease, recurrence, etc.) on the outcome variables with observed between and/or within-group significance. We may perform additional analyses in subgroups or based on protocol non-adherence if applicable.

Analysis of the 16S rRNA sequences will be analysed with QIIME2 (Quantitative Insights into Microbial Ecology software) pipeline. Alpha diversity will be calculated using the richness of ASVs (Amplicon Sequence Variants), Chao1 index, Shannon index and Faith’s phylogenetic diversity and displayed with R software. Beta diversity will be measured using both weighted and unweighted UniFrac distance metrics. Patterns in diversity as a response to the application of RBAC will be visualised with PCoA (Principal Coordinate Analysis) with the statistical significance of groupings validated with an ANOSIM (Analysis Of SIMilarity) test in the context of other potentially interacting variables in the dataset. Differentially abundant microbial taxa which distinguish between treatments will be identified using ANCOM (Analysis of Composition of Microbiomes) and further visualised with the WGCNA (Weighted Correlation Network Analysis) package, ggplot2 packages and stat package in R software with P < 0.05 taken as statistical significance.

Reference:

Whitehead, A. L., Julious, S. A., Cooper, C. L., & Campbell, M. J. (2016). Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Statistical methods in medical research, 25(3), 1057–1073. doi:10.1177/0962280215588241

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13574 0
Daffodil Cottage Cancer Service - West Bathurst
Recruitment postcode(s) [1] 26221 0
2795 - Bathurst West

Funding & Sponsors
Funding source category [1] 302416 0
Commercial sector/Industry
Name [1] 302416 0
Daiwa Pharmaceutical Co., Ltd.
Address [1] 302416 0
1-16-19, Sangenjaya Setagaya-ku, Tokyo, 154-0024, Japan
Country [1] 302416 0
Japan
Funding source category [2] 304759 0
Commercial sector/Industry
Name [2] 304759 0
BioMedica Nutraceuticals Pty Ltd
Address [2] 304759 0
14/34-36 Ralph St
Alexandria NSW 2015
Country [2] 304759 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
School of Biomedical Sciences
Panorama Avenue
BATHURST NSW 2795

Country
Australia
Secondary sponsor category [1] 302314 0
None
Name [1] 302314 0
N/A
Address [1] 302314 0
N/A
Country [1] 302314 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303085 0
Sydney Local Health District HREC (Concord Hospital)
Ethics committee address [1] 303085 0
Ground Floor - Building 20,
Concord Repatriation General Hospital,
Hospital Rd, Concord NSW 2139
Ethics committee country [1] 303085 0
Australia
Date submitted for ethics approval [1] 303085 0
29/03/2019
Approval date [1] 303085 0
12/07/2019
Ethics approval number [1] 303085 0
2019/ETH00489

Summary
Brief summary
The purpose of this research is to investigate the effects of a rice bran arabinoxylan compound (RBAC) as a nutritional supplement on the health-related quality of life (QoL) of cancer patients.

Who is it for?
You may be eligible for this study if you are between 18 and 70 years old, diagnosed with any solid organ cancer, and currently undergoing active treatment.

Study details
Participants in this study will be randomised by chance into two groups. One group will consume 3g per day of the study compound (RBAC) packed in sachets for 24 weeks. The other group will take an inactive placebo treatment for the same period. The assigned intervention will be in addition to your usual cancer care. As part of the study, all participants will complete questionnaires, be weighed and provide blood and stool samples.

Results from this research can improve the understanding of the effect of RBAC during cancer treatment, inform the planning of a larger trial, and supply data to validate the immuno-therapeutic benefits of RBAC.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92418 0
Dr Sokcheon Pak
Address 92418 0
School of Biomedical Sciences
Charles Sturt University
Panorama Avenue
BATHURST NSW 2795

Country 92418 0
Australia
Phone 92418 0
+61 (02) 6338 4952
Fax 92418 0
+61 (02) 6338 4993
Email 92418 0
spak@csu.edu.au
Contact person for public queries
Name 92419 0
Dr Sokcheon Pak
Address 92419 0
School of Biomedical Sciences
Charles Sturt University
Panorama Avenue
BATHURST NSW 2795

Country 92419 0
Australia
Phone 92419 0
+61 (02) 6338 4952
Fax 92419 0
+61 (02) 6338 4993
Email 92419 0
spak@csu.edu.au
Contact person for scientific queries
Name 92420 0
Dr Sokcheon Pak
Address 92420 0
School of Biomedical Sciences
Charles Sturt University
Panorama Avenue
BATHURST NSW 2795

Country 92420 0
Australia
Phone 92420 0
+61 (02) 6338 4952
Fax 92420 0
+61 (02) 6338 4993
Email 92420 0
spak@csu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data (IPD) collected during the trial, after de-identification, may be shared with other institutions for research use upon request.
When will data be available (start and end dates)?
The IPD will be made immediately available following publication with no end date determined.
Available to whom?
IPD will be made available on a case-by-case basis at the discretion of the Primary Sponsor (Charles Sturt University, CSU). CSU reserves the right to impose licensing conditions on the reuse of data.
Available for what types of analyses?
The IPD will be available for any research use subject to any licensing conditions imposed by CSU.
How or where can data be obtained?
The IPD will be made available on the requirement to sign a data access agreement with CSU.
What supporting documents are/will be available?
No other documents available
Summary results
No Results