Antarctic Krill Oil Functional Food Mitigates Bladder Cancer Treatment Side Effects

This randomized, double-blind, placebo-controlled, multicenter trial evaluates the efficacy and safety of Antarctic krill oil in reducing side effects of intravesical therapy for non-muscle-invasive bladder cancer (NMIBC). A total of 210 participants (18-75 years) will be randomized to receive either 2g/day of krill oil capsules (containing phospholipids, DHA, EPA, and astaxanthin) or placebo during intravesical treatment (epirubicin, pirarubicin, or BCG). Primary outcomes include bladder irritation symptoms (IPSS score), systemic adverse events, hematuria, and urinary tract infections. Secondary outcomes assess quality of life (QoL). Safety will monitor adverse events per CTCAE v5.0. The study follows GCP standards and includes rigorous data management and ethical oversight. Results may offer a dietary intervention to improve treatment tolerance and QoL for bladder cancer patients.

NCT Number	NCT06880939
Lead Sponsor	Qilu Hospital of Shandong University Collaborators: The Affiliated Hospital of Qingdao University, Shandong Provincial Hospital
Conditions	Urinary Bladder Neoplasms
Enrollment	210 participants
Start Date	2025-07-15
Primary Completion	2027-05-30 (estimated)
Study Completion	2028-05-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-24