Poster Presentation 2025 Joint Meeting of the COSA ASM and IPOS Congress

Evaluating an Accessible Dietary Fibre Intervention to Improve Outcomes in People with Breast Cancer (The Adhere Study): Protocol for an Open-label, Prospective, Randomised Controlled Pilot Study (125908)

Linh Hang To 1 2 , Joanne Bowen 1 , Hannah Wardill 1 2 , Cassandra Gordon 1 2 , Rohit Joshi 1 3 , Beverly Fosh 1 4 , Sarah Andersen 5 6 , Heidi Staudacher 7 , Monique Bareham 8 , Angela Walls 9 , Courtney Cross 1 2
  1. School of Biomedicine, Faculty of Health and Medical Science, University of Adelaide, Adelaide, South Australia, Australia
  2. Supportive Oncology Group, Precision Medicine (Cancer), South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia
  3. Medical Oncology, Lyell McEwin Hospital, Adelaide, South Australia, Australia
  4. Adelaide Plastic Surgery, Adelaide, South Australia, Australia
  5. Dietetics and Foodservices, Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia
  6. School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia
  7. Medicine Alfred Hospital, Monash University, Melbourne, Victoria, Australia
  8. Health Performance Council, Government of South Australia, Adelaide, South Australia, Australia
  9. Clinical Research Imaging Centre, Dr Jones & Partners, Adelaide, South Australia, Australia

OBJECTIVES/PURPOSE

People with breast cancer are not currently achieving optimal survival outcomes, with ~50% unable to adhere to their intended, life-saving therapy due to severe adverse side effects (e.g. diarrhoea, cognitive impairment, pain). Peripheral, pro-inflammatory mechanisms are responsible for many of these toxic side effects, and preclinical evidence indicates that these pro-inflammatory signals can be reduced by supporting the gut microbiota through the provision of a fibre supplement. However, fibre supplementation has not previously been tested for its ability to reduce side effect symptom burden and thus promote adherence to prescribed maintenance therapy in people with breast cancer.

The Adhere Study is an open-label, prospective, randomised controlled pilot study that aims to determine the tolerability, safety, and efficacy of fibre supplementation in reducing side effect symptom severity and promoting maintenance therapy adherence in people with breast cancer.

SETTING AND PROCEDURES

Adults (N=30) receiving systemic maintenance therapy (targeted-, hormonal- and/or chemotherapy) for breast cancer, at 6- to 24-months post diagnosis, will be randomised at a ratio of 2:1 intervention to control to receive 12g of wheat dextrin, as a dissolvable powder, daily for 3 months. The primary outcome is the overall side effect symptom burden, as determined using the ESAS-r-CS. Secondary outcomes include cognitive symptom burden determined using FACT-Cog, and self-reported maintenance therapy adherence. Exploratory outcomes include brain function and structure assessed using fALFF and DTI on MRI, respectively, gut microbiota composition assessed using faecal samples, and blood-based inflammation biomarker concentrations.

RESULTS

The Adhere Study is scheduled to begin recruitment in Q3 2025.

CONCLUSION AND CLINICAL IMPLICATIONS

The Adhere Study has been designed with the patient at its centre, prioritising PROMs and symptom burden assessed in the chronic setting, where late effects have a significant impact on patient quality of life, especially in the breast cancer setting.