NCT06880939Not yet recruiting
Antarctic Krill Oil Functional Food Mitigates Bladder Cancer Treatment Side Effects
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
Source: ClinicalTrials.gov · Last updated 24 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 11 Mar 2025
- Start date
- 15 Jul 2025
- Primary completion date
- 30 May 2027
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Bladder cancer
- NCT number
- NCT06880939
What you commit to
- Study type: Interventional
- Planned participants: 210
- From 15 Jul 2025 to the primary completion date, 30 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.