None listed
Conditions
Brief summary
This study aims to determine the tolerability, safety and efficacy of fibre supplementation to reduce side effect symptom severity and promote maintenance therapy adherence in people with breast cancer Who is it for? You may be eligible to join this study if you are aged 18 years or older, currently receiving systemic maintenance therapy (including chemotherapy, endocrine therapy and/or targeted therapy) for breast cancer, at 6 to 18 months following initial diagnosis, experience side effects to your maintenance therapy and are able to provide informed consent to all trial related procedures. Study details All participants who meet the eligibility criteria in this study will be randomised to either the intervention or control group. In the intervention group, all participants will be provided with a fibre supplement daily for 3 months, whilst on maintenance therapy for breast cancer. The control will continue with their current maintenance therapy and standard care. They will be offered the fibre supplement 1 month after the intervention has been completed. During and post intervention, participants will be assessed for side effects, dose modification, adverse events, gut microbiota, and brain structure. It is hoped that this research project will provide the first evidence supporting the beneficial role of fibre in reducing breast cancer treatment side effects, informing larger scale trials to produce the knowledge required for clinical implementation of fibre as a supportive cancer care strategy.
Interventions
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 wil
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.
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
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
Outcome results
None listed