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Antarctic Krill Oil Functional Food Mitigates Bladder Cancer Treatment Side Effects
Sponsor: Qilu Hospital of Shandong University
Summary
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.
Official title: Randomized, Double-Blind, Parallel-Controlled, Multicenter Clinical Study on the Efficacy of Antarctic Krill Oil Functional Food in Alleviating Side Effects of Intravesical Therapy for Bladder Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2025-07-15
Completion Date
2028-05-30
Last Updated
2025-07-24
Healthy Volunteers
No
Conditions
Interventions
Krill Oil Functional Food
Take 2g of krill oil orally daily, with each krill oil capsule containing 1g, by consuming one capsule within 30 minutes after breakfast and one capsule within 30 minutes after dinner. The supplementation period begins on the day of the first bladder instillation treatment and continues until the day of the last bladder instillation treatment.
Olive Oil
Instead of taking krill oil orally, use placebo capsules that are visually similar, with the contents being olive oil, each capsule containing 1g. Take one capsule within 30 minutes after breakfast and one capsule within 30 minutes after dinner. The duration of intake begins on the day of the first bladder instillation treatment and continues until the day of the last bladder instillation treatment.
Locations (1)
Qilu Hospital of Shandong University
Jinan, Shandong, China