Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001128785
Ethics application status
Approved
Date submitted
15/07/2022
Date registered
16/08/2022
Date last updated
26/10/2022
Date data sharing statement initially provided
16/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of anti-inflammatory dietary intervention on dietary inflammatory load in oncology patients undergoing immunotherapy with check point inhibitors , with or without chemotherapy : A single arm feasibility study
Scientific title
Effect of anti-inflammatory dietary intervention on dietary inflammatory load in oncology patients undergoing immunotherapy with check point inhibitors , with or without chemotherapy : A single arm feasibility study
Secondary ID [1] 307588 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 327031 0
inflammation 327197 0
Condition category
Condition code
Diet and Nutrition 324203 324203 0 0
Other diet and nutrition disorders
Cancer 324204 324204 0 0
Any cancer
Inflammatory and Immune System 324205 324205 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single arm Pilot trial. Mediterranean diet will be provided to immunotherapy patients starting cancer therapy from the commencement of treatment until 12 weeks from commencement.

The patient's diet will be individualised and modified so its Mediterranean Diet Score (MDS) is 11 or above. Diet will be oral. As soon as the patient is diagnosed with cancer and a immunotherapy treatment plan is decided, their consent to join the study will be determined. Dietary data in the form of a diet history and FFQ (validated https://www.mdpi.com/2072-6643/13/12/4557) will be collected on phone, video call or in person anytime before the commencement of immunotherapy treatment by an Accredited Practicing Dietitian. This interview may span between 1-2 hours depending on the patient. A written diet plan with goals and specific strategies will be provided to the patients on their next in person visit to the hospital and they will be advised to commence recommended diet on the day of immunotherapy commencement.

The proposed individualised modifications will follow the following guidelines :
-Participants asked to consume 4 or more tbsp. of extra virgin olive oil EVOO every day (50g)
-Participants asked to consume 3 or more serves of nuts per day (30 g composed of 15 g of walnuts, 7.5 g of almonds and 7.5 g of hazelnuts)
Participants asked to:
-Include 3 or more portions of fresh fruits per day (more than 300g per day)
-Include 5 or more portions of vegetables/legumes per day (more than 250g per day)
-Include 3 or more portions of fatty fish or seafood per week (more than 250 g per day)
-Replace red meat with white meat (meat less than 80 g per day)
-Drink wine with meals (habitual drinkers)
-Limit soda drink to 1 or less portion per day
-Limit bakery goods, sweets, and pastries to 3 or less portions per week
-Limit fat spreads to 1 or less portion per day
-Limit red processed meats to 1 or less portion per day
-Limit dairy to 2 or less portions (less than 270 g per day)

On the day when a written copy of the diet plan will be provided to the patients, they will also be initially provided with commercially purchased complimentary packs of mixed nuts (250g) and extra virgin olive oil (EVOO - 500 ml). Other recommended items would have to be purchased by the patients at their discretion. Additionally, nuts and EVOO for the rest of the duration of the diet intervention will also have to be purchased by the participants.

Participants will not be provided macronutrient goals, however they will be provided goals such as your fish intake needs to be increased to xxx g/day. In the written copy, they will be provided with indications about the weight of a serve etc and will also be provided with specific strategies to achieve the same.

Participants will be asked to complete a MDS checklist everyday and an Accredited Practicing Dietitian will follow up with patients weekly over phone. In case the patient experiences any difficulties filling up the MDS checklist, they will be provided a number to contact the dietitian for help.
Intervention code [1] 324037 0
Prevention
Intervention code [2] 324142 0
Lifestyle
Comparator / control treatment
Historical Control group that received no dietary intervention (no treatment) during their treatment period

Historical control data was collected from 19 July 2021 to 16 November 2021 for patients that received immunotherapy (with or without chemotherapy) from Flinders Medical Centre from electronic and hard copy case notes.

These patients did not receive Mediterranean diet as a dietary intervention (usual care) therefore they are controls.

The same data that will be collected from the intervention groups has already been collected for the control group. This includes relevant background information, treatment regime, diet history data, FFQ, side effects experienced from commencement until 12 weeks of treatment and so on. Inflammation marker data which will be collected for the intervention group was not available for historical cohorts.
Control group
Historical

Outcomes
Primary outcome [1] 332930 0
The study would be deemed feasible if all the following are met:
1. if greater than or equal to 70% of the participants completed the study until 12 weeks . Withdrawal from study and loss to follow up until the end of 12 weeks will be considered failure to complete study.
2. If greater than or equal to 70% of the participants that complete the study, with a baseline MDS score of less than 11 achieve an improvement of at least 2 points in the MDS calculated using a 18 point MDS tool, this study would be deemed feasible .
3. If the participants with a baseline MDS score of 11 or more will maintain or improve MDS score at follow up.
Timepoint [1] 332930 0
Baseline vs 12 weeks follow up
Secondary outcome [1] 411927 0
Inflammation will be assessed using C-reactive protein, interleukin 6, Tumour necrosis factor- alpha and interleukin-10. This outcome will be measured using blood tests and the medical records (blood test results will be accessed for this information)
Timepoint [1] 411927 0
Baseline vs 12 weeks post intervention commencement
Secondary outcome [2] 411928 0
Dietary Inflammatory Index (DII)
Timepoint [2] 411928 0
Baseline vs 12 weeks post intervention commencement
Secondary outcome [3] 411929 0
Food Frequency Questionnaire (FFQ) inflammatory score
Timepoint [3] 411929 0
Baseline vs 12 weeks
Secondary outcome [4] 412345 0
Adherence to treatment using MDS checklist, diet history and FFQ
Timepoint [4] 412345 0
MDS checklist (daily)
Diet history and FFQ (baseline and 12 weeks post treatment commencement)
Secondary outcome [5] 412346 0
Personal experience using an evaluation set of questions. It will be called 'Post intervention questionnaire'. It is not validated and it is designed specifically for this study.
Timepoint [5] 412346 0
At end of treatment (12 weeks post treatment commencement)
Secondary outcome [6] 412347 0
To collect data on barriers (taste, side effects, cost, difficulty in shopping or cooking, motivation level, confidence, time burden) will be collected via a qualitative questionnaire called 'Post intervention questionnaire'. No changes to the questionnaire have been made.
Timepoint [6] 412347 0
After end of treatment (12 weeks post treatment commencement)
Secondary outcome [7] 415189 0
Immune related adverse events The adverse events such as Gastrointestinal and hepatotoxicity, skin toxicity, pulmonary toxicity, renal toxicity, neurological toxicity, endocrine toxicity, and fatigue will be assessed using the common terminology criteria for adverse events (CTCAE). These forms are completed by the nursing staff and medical records will be used to access this information.
Timepoint [7] 415189 0
Across 12 weeks post immunotherapy (and dietary intervention) commencement. The nursing staff complete common terminology criteria for adverse events (CTCAE) forms using grading scale 0-nil; 1-mild; 2-moderate; 3-severe; 4-life threatening during in person visits to hospital. The maximum score between cycles (including on the day of treatment) will be documented. The duration of treatment cycle varies for different patients. All information related to side effects from commencement of treatment until 12 weeks from commencement will be collected.

Eligibility
Key inclusion criteria
Patients newly diagnosed with any cancer about to commence immunotherapy (with or without chemotherapy)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age 17 or less
• Predicted to be unable to consume food orally at start of cancer therapy
• Patients on enteral and/or parenteral feeds
• Presence of allergies (related to nuts, fish etc.)
• Barriers preventing completion of diet histories
• Patients for whom Ms Mukherjee is the treating dietitian
• Non-English speaking

Study design
Purpose of the study
Prevention
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
Safety/efficacy
Statistical methods / analysis
Based on an one arm binomial calculation, assuming an improvement of 2 points on MDS in at least 70% of the participants receiving the intervention, for a two sided test, with power set at 0.9 and an alpha set at 0.05, a sample size of 6 is estimated.
Some studies suggest that a sample size of 12 is appropriate for a pilot study while others recommend a sample size of 30 . Based on these recommendations for pilot studies, this study will aim to recruit a minimum of 12 patients (with an MDS score of less than 11) and a maximum of 30, receiving immunotherapy with CPIs, with or without chemotherapy. This pilot study will help determine appropriate sample size and feasibility for future trials. The sample sizes of pilot trials using Mediterranean diet have ranged from 8 to 65 participants and therefore 12 is considered a reasonable target. The study will be conducted at the Flinders Medical Centre where approximately 2-5 new patients are treated with immunotherapy drugs every week. Assuming an enrolment of 1 patient per week and a 20% attrition rate, 12 participants over a period of 4 months is considered feasible.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/11/2022
Actual
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
29/05/2023
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 22840 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 38138 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 311858 0
University
Name [1] 311858 0
Flinders University Research Maintenance funds
Country [1] 311858 0
Australia
Funding source category [2] 311942 0
University
Name [2] 311942 0
Flinders University - in kind support from Supervisors
Country [2] 311942 0
Australia
Primary sponsor type
University
Name
Flinders Univeristy
Address
Sturt Road, Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 313332 0
None
Name [1] 313332 0
NA
Address [1] 313332 0
NA
Country [1] 313332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311297 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 311297 0
Sturt Road, Bedford Park SA 5042
Ethics committee country [1] 311297 0
Australia
Date submitted for ethics approval [1] 311297 0
27/06/2022
Approval date [1] 311297 0
26/08/2022
Ethics approval number [1] 311297 0

Summary
Brief summary
The aim of this study is to determine if Mediterranean diet can be followed by diagnosed cancer patients about to commence immunotherapy.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, and are about to commence immunotherapy (with or without chemotherapy).

Study details
All participants will attend a 1-2 hour session with a dietitian to develop a diet plan, where the participant’s existing diet will be modified to meet the requirements of a Mediterranean diet through addition of extra virgin olive oil and nuts to the diet as well as setting goals to meet vegetables, fruits, fish, legumes, meat and dairy requirements. This diet plan will be followed from the time of commencement of immunotherapy treatment until 12 weeks from commencement. Throughout the 12-week study period, participants will be monitored for immune related adverse events through through data collection from medical records. Before and after commencing the dietary intervention, participants will also complete questionnaires regarding their dietary intake, and will have blood samples taken for the assessment of inflammatory markers. These outcomes will be compared to a cohort of 53 cancer patients from a similar setting who received no dietary intervention in the past.

It is hoped that this study may show that a Mediterranean diet can be successfully followed by the participants and reduces the degree of immune related adverse events and markers of inflammation in patients undergoing immunotherapy for cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120614 0
Dr Shawgi Sukumaran
Address 120614 0
College of Nursing and Health Sciences, Flinders University, Sturt Rd, Bedford Park, South Australia 5042
Country 120614 0
Australia
Phone 120614 0
+61 431 746 142
Fax 120614 0
Email 120614 0
shawgi.sukumaran@flinders.edu.au
Contact person for public queries
Name 120615 0
Miss Mitali Mukherjee
Address 120615 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 120615 0
Australia
Phone 120615 0
+61 420 264 042
Fax 120615 0
Email 120615 0
mitali.mukherjee@flinders.edu.au
Contact person for scientific queries
Name 120616 0
Prof Michelle Miller
Address 120616 0
Flinders University, Sturt Rd, Bedford Park, South Australia 5042
Country 120616 0
Australia
Phone 120616 0
+61 08 82012421
Fax 120616 0
Email 120616 0
michelle.miller@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16648Study protocol    384389-(Uploaded-24-10-2022-16-25-39)-Study-related document.docx
16649Informed consent form    384389-(Uploaded-24-10-2022-16-26-04)-Study-related document.docx



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.