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Trial registered on ANZCTR


Registration number
ACTRN12625000653460
Ethics application status
Approved
Date submitted
13/12/2024
Date registered
20/06/2025
Date last updated
20/06/2025
Date data sharing statement initially provided
20/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating an accessible dietary fibre intervention on overall side effect burden in people with breast cancer
Scientific title
The Adhere Study: evaluating an accessible dietary fibre intervention on overall side effect burden in people with breast cancer
Secondary ID [1] 313561 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ADHERE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Side effects of maintenance treatment for breast cancer. 336080 0
Cancer-related cognitive impairment 336082 0
Condition category
Condition code
Cancer 332638 332638 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Benefiber Chewable tablets taken adjunctively during maintenance therapy for breast cancer.
3 Benefiber Chewable tablets will be taken 2 times daily (12g wheat dextrin daily), with a meal and glass of liquid, for 3 months. The intervention will be taken in addition to standard of care.

Participants will report any deviation from instructed dosing of the interventional product using a diary. Self-reported adherence will be assessed through a 10 minute, monthly phone call where investigators will ask participants if they have missed or altered their dose of fibre.
Intervention code [1] 330160 0
Treatment: Other
Comparator / control treatment
Observational, control arm, providing data on side effect severity, self-reported rate of maintenance therapy (i.e. systemic hormone, targeted and/or chemotherapy) dose modification and biospecimens in concurrent patients with breast cancer. When participants in the observational control arm meet the primary endpoint of the study, they will be offered a 1-month course of fibre supplements.
Control group
Active

Outcomes
Primary outcome [1] 340142 0
Overall side effect burden.
Timepoint [1] 340142 0
Baseline and at 3 months of fibre supplementation.
Secondary outcome [1] 442961 0
Proportion of participants who self-report 2 or more dose modifications to breast cancer treatments.
Timepoint [1] 442961 0
Baseline, and monthly during the 3 month study period.
Secondary outcome [2] 442962 0
Cognitive side effect burden.
Timepoint [2] 442962 0
Baseline and at 3 months of fibre supplementation.
Secondary outcome [3] 442963 0
Incidence of fibre-emergent adverse events.
Timepoint [3] 442963 0
Baseline and monthly during the 3 month study period.
Secondary outcome [4] 442964 0
Dose of fibre achieved.
Timepoint [4] 442964 0
At completion of the 3 month study period.
Secondary outcome [5] 442965 0
Gut microbiota composition.
Timepoint [5] 442965 0
Baseline and at 3 months of fibre supplementation.
Secondary outcome [6] 442966 0
Concentration of short-chain fatty acids (SCFAs).
Timepoint [6] 442966 0
Baseline and at 3 months of fibre supplementation.
Secondary outcome [7] 442967 0
Brain function (pre-frontal cortex and hippocampus).
Timepoint [7] 442967 0
Baseline and at 3 months of fibre supplementation.
Secondary outcome [8] 442968 0
Brain structure.
Timepoint [8] 442968 0
Baseline and at 3 months of fibre supplementation.

Eligibility
Key inclusion criteria
1. Adult, 18 years or older
2. Currently receiving systemic maintenance therapy (including chemotherapy, hormone therapy and/or targeted therapy) for breast cancer
3. At 6 to 18 months following initial diagnosis
4. Baseline Total Symptom Distress Score > 9
5. Able to provide informed consent and follow all clinical trial related procedures (to ensure equity in access to this trial, we will work with the Translator Service at the study sites to make this study available to CALD communities).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pre-existing gastrointestinal disease including Crohn’s disease, ulcerative colitis and coeliac disease
2. Prior gastrointestinal surgery including bariatric, intestinal resection and ileostomy / colostomy
3. Pregnancy or breastfeeding
4. Coeliacs disease or allergy to product ingredients: wheat dextrin, sorbitol, corn starch, microcrystalline cellulose, dextrates, citric acid, natural and artificial flavor (soy), magnesium stearate, silicon dioxide, sucralose, aspartame, acesulfame potassium
5. Total Symptom Distress Score less than 9 on ESAS-r-CS

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)
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Prospective, open-label, randomised study with an observational control arm.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Outcomes will be evaluated in participants randomised to receive the intervention and compared to an observational control arm. Non-repeated measures will be compared using an unpaired t-test (parametric data) or Mann-Whitney U test (non-parametric data). Repeated measure data will be analysed using mixed models and under the expertise of bioinformaticians.

This is a pilot study aiming to recruit N=20 active participants, who reach the primary endpoint of the study (3 months of fibre supplementation), and N=10 concurrent, observational controls. This is due to the fact that N=20 participants are sufficient for us to detect a 40% reduction in the proportion of participants that report the development of cognitive impairment (defined by a FACT-Cog score >106.6), with alpha = 0.05, power 90%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/07/2025
Actual
Date of last participant enrolment
Anticipated
12/01/2026
Actual
Date of last data collection
Anticipated
12/04/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318024 0
Charities/Societies/Foundations
Name [1] 318024 0
Tour De Cure
Country [1] 318024 0
Australia
Funding source category [2] 318032 0
Other
Name [2] 318032 0
South Australian Health and Medical Research Institute (SAHMRI) BRIGHT Sparks Award.
Country [2] 318032 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 320377 0
None
Name [1] 320377 0
Address [1] 320377 0
Country [1] 320377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316682 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 316682 0
Ethics committee country [1] 316682 0
Australia
Date submitted for ethics approval [1] 316682 0
15/07/2024
Approval date [1] 316682 0
05/09/2024
Ethics approval number [1] 316682 0
2024/HRE00163

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

Contacts
Principal investigator
Name 138650 0
Dr Courtney Cross
Address 138650 0
L5S, South Australian Health and Medical Research Institute (SAHMRI), North Terrace, Adelaide, 5000
Country 138650 0
Australia
Phone 138650 0
+61 420713484
Fax 138650 0
Email 138650 0
[email protected]
Contact person for public queries
Name 138651 0
Courtney Cross
Address 138651 0
L5S, South Australian Health and Medical Research Institute (SAHMRI), North Terrace, Adelaide, 5000
Country 138651 0
Australia
Phone 138651 0
+61 420713484
Fax 138651 0
Email 138651 0
[email protected]
Contact person for scientific queries
Name 138652 0
Courtney Cross
Address 138652 0
L5S, South Australian Health and Medical Research Institute (SAHMRI), North Terrace, Adelaide, 5000
Country 138652 0
Australia
Phone 138652 0
+61 420713484
Fax 138652 0
Email 138652 0
[email protected]

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


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Other    The Adhere Study Flyer_V3_12June2025.pdf


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.