None listed
Conditions
Brief summary
This study will investigate the feasibility of a High Fibre Dietary Intervention in patients with Melanoma receiving Neoadjuvant Immune Checkpoint Inhibitors Who is it for? You may be eligible to join this study if you are aged 18 years or above with a histologically or cytologically confirmed diagnosis of Stage III or IV melanoma, naïve to immune checkpoint therapy and planned for neoadjuvant pembrolizumab. Study details All participants in this study will receive a dietician-led dietary counselling intervention over 9 weeks to escalate daily fibre intake to >30g per day. The intervention will be undertaken face to face or via telehealth and will involve provision of resources including recipes and meal plans, fibre-counting tables, and individualised advice. Adherence will be assessed via 3-day food records while safety and tolerance to the dietary intervention will be assessed via questionnaires. This intervention will help establish whether a dietician-led counselling intervention can successfully help escalate fibre intake in an area where a high-fibre diet may be important in improving responses to immune checkpoint therapy.
Interventions
This study involves a 9 week dietician-led dietary counselling intervention to escalate daily fibre intake to >30g per day, concurrent with a neoadjuvant immune therapy regimen for melanoma planned for surgical resection (Stage III or IV). The dietician will be experienced in the management of oncology patients and have motivational interview training. This involves a telehealth or face-to-face dietician consult at baseline (60 minutes), with provision of written resources developed specifically for the study (tables with fibre estimates for foods and portions, recipes, suggested meal plan and information sheet on the gut microbiome and impact of diet) and suggestion of use of the Easy Diet App. Further dietary consultations at weeks 1, 2, 3, 5, 7 and 9 (approx 30 minutes) will be undertaken. Based on their initial food frequency survey results and baseline 3-day food record result, the dietician will explore ways in which patients can adapt their diet and individualise recommendations for how fibre can be escalated. The dietary intervention occurs concurrently with 3 cycles of pembrolizumab (a standard of care), over a 9 week period. Surgery to remove the melanoma will occur from week 10 to 12 (also a standard of care). 3-day food records will be collected at baseline and at the end of weeks 3, 6 and 9 from which fibre intake will be measured. Although self-reported by patients, these will be verified by the dietician to optimise accuracy.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients will be eligible for inclusion in this trial if all the following criteria apply: 1. Written informed consent 2. Histologically or cytologically confirmed cutaneous Stage III or IV melanoma (mucosal/uveal excluded) 3. Patients at least 18 years of age 4. Naïve to immune checkpoint therapy and planned for neoadjuvant pembrolizumab 5. Screening laboratory values within an acceptable range for treatment (as per standard of care/clinician discretion) 6. Baseline PET-CT or CT imaging within 4 weeks of neoadjuvant therapy commencement 7. Males and females of childbearing age must be willing to use adequate contraception
Exclusion criteria
Patients will not be eligible for inclusion in this trial if any of the following criteria apply: 1. Any of the following underlying gastrointestinal conditions: • active diverticular disease • inflammatory bowel disease • coeliac disease • altered gastrointestinal anatomy 2. Significant diet restriction required eg for multiple allergies or food intolerances 3. Following a different diet not compatible with trial 4. Baseline dietary fibre >25g/day (as estimated by Australian Eating Survey) 5. Unable to undertake Telehealth dietitian-led interventions or no access to smart phone. 6. Any current immune-suppressive therapy, including biologic immunomodulators or corticosteroids >10mg oral prednisolone (or equivalent), within the last 8 weeks 7. Current or recent antibiotic use within the last 30 days 8. Uncontrolled intercurrent illness, including psychiatric illness, or social scenario that would affect compliance with proposed intervention (eg living in Aged Care Facility where all meals provided) 9. Participant in another therapeutic clinical trial with an investigative agent 10. Pregnancy