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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001128785
Enrollment
12
Registered
2022-08-16
Start date
2022-11-14
Completion date
2023-04-19
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 an

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.

Sponsors

Flinders Univeristy
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients newly diagnosed with any cancer about to commence immunotherapy (with or without chemotherapy)

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

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026