Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000525482
Ethics application status
Approved
Date submitted
6/05/2025
Date registered
26/05/2025
Date last updated
26/05/2025
Date data sharing statement initially provided
26/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
High Fibre Dietary Intervention in patients with Melanoma receiving Immune Checkpoint Inhibitors (HiFi-Mel)
Scientific title
Feasibility study of a High Fibre Dietary Intervention in patients with Melanoma receiving Neoadjuvant Immune Checkpoint Inhibitors (HiFi-Mel)
Secondary ID [1] 314384 0
nil known
Universal Trial Number (UTN)
Trial acronym
HiFi-Mel
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 337387 0
Condition category
Condition code
Cancer 333766 333766 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330996 0
Lifestyle
Comparator / control treatment
No active control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341348 0
Adherence to the high fibre diet (ie ability to escalate to and sustain >30g per day of fibre)
Timepoint [1] 341348 0
baseline, end of week 3, 6 and 9; week 6 and 9 results will be used to determine adherence
Secondary outcome [1] 447205 0
Safety of the dietary intervention during immune checkpoint therapy
Timepoint [1] 447205 0
At weeks 4, 7 and 10 (ie coinciding with pre- and post-pembrolizumab safety visits)
Secondary outcome [2] 447206 0
Range of fibre intake achieved
Timepoint [2] 447206 0
3-day food records at baseline, end of week 3, 6 and 9
Secondary outcome [3] 447207 0
Pathologic response rate to neoadjuvant pembrolizumab
Timepoint [3] 447207 0
Result of surgery at week 10-12
Secondary outcome [4] 447208 0
Imaging response rate
Timepoint [4] 447208 0
Baseline and at week 10-12 (post 3 cycles of pembrolizumab, as a standard of care)
Secondary outcome [5] 447209 0
Event free survival
Timepoint [5] 447209 0
12 and 24 months from start of intervention
Secondary outcome [6] 447687 0
Tolerance of the intervention
Timepoint [6] 447687 0
Baseline, week 2, 3, 6 and 9
Secondary outcome [7] 447688 0
Melanoma-specific survival
Timepoint [7] 447688 0
12 and 24 months from enrolment
Secondary outcome [8] 447689 0
Overall survival
Timepoint [8] 447689 0
12 and 24 months from enrolment
Secondary outcome [9] 447690 0
Financial impact of dietary intervention
Timepoint [9] 447690 0
Baseline and week 9
Secondary outcome [10] 447691 0
Acceptability of diet
Timepoint [10] 447691 0
DSS at week 9, semi-structured interview week 10-12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2025
Actual
Date of last participant enrolment
Anticipated
28/05/2027
Actual
Date of last data collection
Anticipated
26/05/2028
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27895 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 44091 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 318902 0
Charities/Societies/Foundations
Name [1] 318902 0
Philanthropic donation
Country [1] 318902 0
Australia
Funding source category [2] 318989 0
Government body
Name [2] 318989 0
NHMRC SYNERGY grant
Country [2] 318989 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 321366 0
None
Name [1] 321366 0
Address [1] 321366 0
Country [1] 321366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317517 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 317517 0
Ethics committee country [1] 317517 0
Australia
Date submitted for ethics approval [1] 317517 0
01/04/2025
Approval date [1] 317517 0
30/04/2025
Ethics approval number [1] 317517 0

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

Contacts
Principal investigator
Name 141302 0
Dr Lavinia Spain
Address 141302 0
Peter MacCallum Cancer Centre, 305 Grattan Street Parkville, VIC 3000
Country 141302 0
Australia
Phone 141302 0
+61 38559 7902
Fax 141302 0
Email 141302 0
[email protected]
Contact person for public queries
Name 141303 0
Lavinia Spain
Address 141303 0
Peter MacCallum Cancer Centre, 305 Grattan Street Parkville, VIC 3000
Country 141303 0
Australia
Phone 141303 0
+61 38559 7902
Fax 141303 0
Email 141303 0
[email protected]
Contact person for scientific queries
Name 141304 0
Lavinia Spain
Address 141304 0
Peter MacCallum Cancer Centre, 305 Grattan Street Parkville, VIC 3000
Country 141304 0
Australia
Phone 141304 0
+61 38559 7902
Fax 141304 0
Email 141304 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This will be considered in time, ie pending recruitment



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.