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

Not Applicable

• Conditions: cancer; inflammation; Diet and Nutrition - Other diet and nutrition disorders; Cancer - Any cancer; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12622001128785
• Lead Sponsor: Flinders Univeristy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-16
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The study would be deemed feasible if all the following are met: <br>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. <br>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 . <br>3.If the participants with a baseline MDS score of 11 or more will maintain or improve MDS score at follow up.<br>[Baseline vs 12 weeks follow up]