Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001118392p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
17/08/2026
Date registered
Help: Date registered
9/09/2026
Date last updated
Help: Date last updated
9/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
9/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of rice bran arabinoxylan compound (RBAC) supplementation on the nutritional status of participants with colorectal cancer.
Scientific title
A pilot, randomised study to evaluate the effects of orally administered modified rice bran arabinoxylan compound (RBAC) on the nutritional status of participants with colorectal cancer.
Additional trial identifiers [1] 317749 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Malnutrition 343172 0
Cachexia 343173 0
Nutritional status 343174 0
colorectal cancer 343415 0
Condition category
Condition code
Alternative and Complementary Medicine 339254 339254 0 0
Other alternative and complementary medicine
Cancer 339559 339559 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Diet and Nutrition 339560 339560 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Rice bran arabinoxylan compound (RBAC). Administered orally 3 g once daily for 24 weeks. Adherence will be monitored through remaining sachet counts during the follow-up visits.
Intervention code [1] 335015 0
Treatment: Other
Description of the comparator or control
The control group will receive a placebo in powder form, matched to the Rice bran arabinoxylan compound (RBAC) intervention in appearance, taste and administration schedule. The placebo will be administered for 24 weeks at the same dosage and frequency as the intervention group (3 g once daily).
Control group
Placebo

Outcomes
Primary outcome [1] 346543 0
Controlling nutritional status score (CONUT score; assessed as a composite outcome).
Timepoint [1] 346543 0
Baseline, Week 6, 12, 18, 24 post-intervention commencement.
Secondary outcome [1] 466330 0
Malnutrition
Timepoint [1] 466330 0
Baseline, Week 6, 12, 18, 24 post-intervention commencement.
Secondary outcome [2] 466331 0
Cachexia-related quality of life
Timepoint [2] 466331 0
Baseline, Week 6, 12, 18, 24 post-intervention commencement.
Secondary outcome [3] 466332 0
Neutrophil to Lymphocyte ratio
Timepoint [3] 466332 0
Baseline, Week 6, 12, 18, 24 post-intervention commencement.
Secondary outcome [4] 466333 0
Quality of life
Timepoint [4] 466333 0
Baseline, Week 6, 12, 18, 24 post-intervention commencement.
Secondary outcome [5] 466334 0
Fatigue
Timepoint [5] 466334 0
Baseline, Week 6, 12, 18, 24 post-intervention commencement.
Secondary outcome [6] 466335 0
Gut microbiome
Timepoint [6] 466335 0
Baseline, Week 6, 12, 18, 24 post-intervention commencement.
Secondary outcome [7] 466336 0
The tryptophan-kynurenine pathway
Timepoint [7] 466336 0
Baseline, Week 6, 12, 18, 24 post-intervention commencement.
Secondary outcome [8] 467259 0
Platelet to Lymphocyte ratio
Timepoint [8] 467259 0
Baseline, Week 6, 12, 18, 24 post-intervention commencement.
Secondary outcome [9] 467260 0
Systemic Immune-Inflammation Index (SII)
Timepoint [9] 467260 0
Baseline, Week 6, 12, 18, 24 post-intervention commencement.
Secondary outcome [10] 467261 0
NP/LHb index
Timepoint [10] 467261 0
Baseline, Week 6, 12, 18, 24 post-intervention commencement.

Eligibility
Key inclusion criteria
Histologically confirmed diagnosis of colorectal adenocarcinoma at stage II or above and currently undergoing chemotherapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Known or possible pregnancy, demonstrated inability to complete questionnaires, prognosis with a projected survival period of less than six months.

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation by baseline Controlling nutritional status score.
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322291 0
Commercial sector/Industry
Name [1] 322291 0
Daiwa Pharmaceutical Co., Ltd.
Country [1] 322291 0
Japan
Primary sponsor type
University
Name
Charles Sturt University
Address
Country
Australia
Secondary sponsor category [1] 325662 0
None
Name [1] 325662 0
Address [1] 325662 0
Country [1] 325662 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320802 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 320802 0
Ethics committee country [1] 320802 0
Australia
Date submitted for ethics approval [1] 320802 0
04/05/2026
Approval date [1] 320802 0
Ethics approval number [1] 320802 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151682 0
Dr Peter Micalos
Address 151682 0
Charles Sturt University, 7 Major Innes Road, Port Macquarie NSW 2444
Country 151682 0
Australia
Phone 151682 0
+61 2 6582 9495
Fax 151682 0
Email 151682 0
[email protected]
Contact person for public queries
Name 151683 0
Peter Micalos
Address 151683 0
Charles Sturt University, 7 Major Innes Road, Port Macquarie NSW 2444
Country 151683 0
Australia
Phone 151683 0
+61 2 65829495
Fax 151683 0
Email 151683 0
[email protected]
Contact person for scientific queries
Name 151684 0
Peter Micalos
Address 151684 0
Charles Sturt University, 7 Major Innes Road, Port Macquarie NSW 2444
Country 151684 0
Australia
Phone 151684 0
+61 2 65829495
Fax 151684 0
Email 151684 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.