Tests krill oil supplement to ease bladder cancer treatment side effects
Tests krill oil capsules, or a placebo, in adults receiving bladder cancer drug treatment.
Plain-language title generated from the registry record
Registry title: Antarctic Krill Oil Functional Food Mitigates Bladder Cancer Treatment Side Effects
Key facts
- Where
- Jinan, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06880939, who can take part
Where in China
- Qilu Hospital of Shandong UniversityJinan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qilu Hospital of Shandong University
- Trial code
- NCT06880939
- Record updated
- 24 July 2025
- Original description
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).Read full original descriptionShow less
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
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.
Inclusion: 1. Diagnosed bladder cancer: The patient needs to be diagnosed with bladder cancer through pathological examination and have undergone bladder cancer surgery; 2. Planned to receive bladder infusion therapy: Patients need to plan to receive bladder infusion therapy after surgery and agree to participate in the study; 3. Age range: 18 to 75 years old; 4. Normal blood, liver and kidney function: Laboratory tests showed that the patient's blood routine, liver function and kidney function were within the normal range; 5. Signed informed consent: The patient understands the content of the study and voluntarily signs the informed consent.
Exclusion: 3. History of prior chemotherapy: Patients who have received perfusion therapy prior to this study; 6. Psychiatric illness: Patients with a history of severe psychiatric illness or currently receiving treatment for psychiatric illness; 1. Serious comorbidities: including but not limited to heart disease, severe liver and kidney insufficiency, uncontrolled hypertension, diabetes, etc; 2. History of allergies: Patients with a known history of allergy to krill oil or perfusion drug components; 4. History of other malignant tumors: Patients with a history of other malignant tumors; 8. Other: Other conditions that the investigator considers unsuitable to participate in this study; 5. Pregnancy or lactation: Female patients who are pregnant or lactating; 7. Poor study compliance: Patients who believe that they are unable to complete the entire trial process as required by the study.