Clinical trial NCT06880939: Antarctic Krill Oil Functional Food Mitigates Bladder Cancer Treatment Side Effects
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Bladder Neoplasms
Keywords: Bladder Cancer
Krill Oil
Intravesical Therapy
Adverse Effects
Randomized Controlled Trial
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of Qingdao University
name: Shandong Provincial Hospital
First posted: 2025-03-18
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Experimental Group:

   Dosage: Oral administration of 2g krill oil daily. The krill oil supplement is provided in 1g capsules, with one capsule taken 30 minutes after breakfast and one capsule 30 minutes after dinner.

   Duration: The supplementation begins on the day of the first bladder instillation treatment and continues until the day of the last bladder instillation treatment.
2. Control Group:

Intervention: No krill oil is administered. Instead, a placebo capsule with a similar appearance is used, containing olive oil. The placebo is provided in 1g capsules, with one capsule taken 30 minutes after breakfast and one capsule 30 minutes after dinner.

Duration: The placebo administration begins on the day of the first bladder instillation treatment and continues until the day of the last bladder instillation treatment.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This randomized, double-blind, placebo-controlled, multicenter clinical trial aims to evaluate the efficacy and safety of Antarctic krill oil functional food in alleviating side effects of intravesical therapy for bladder cancer. The study will enroll 210 participants (105 per group) aged 18-75 years with histologically confirmed non-muscle-invasive bladder cancer (NMIBC) who are scheduled to undergo postoperative intravesical therapy (e.g., epirubicin, pirarubicin, or BCG). Participants will be randomized to receive either 2g/day of krill oil capsules (containing phospholipids, DHA, EPA, and astaxanthin) or placebo (olive oil capsules) during their intravesical treatment period.

The primary outcomes include the reduction in bladder irritation symptoms (assessed via IPSS score), incidence of systemic adverse events (e.g., nausea, fatigue), hematuria, and urinary tract infections. Secondary outcomes focus on quality of life (QoL) improvements using standardized questionnaires. Safety monitoring will track adverse events related to krill oil or intravesical therapy, graded per CTCAE v5.0 criteria.

Statistical analyses will compare groups using t-tests, chi-square tests, repeated-measures ANOVA, and Cox regression models. The study anticipates a medium effect size (d=0.5) with 90% power and accounts for a 20% dropout rate. Conducted across three centers in China (Qilu Hospital of Shandong University, Qingdao University Affiliated Hospital, and Shandong Provincial Hospital), the trial adheres to GCP standards and includes rigorous data management, adverse event reporting, and ethical oversight. Results may offer a novel dietary intervention to improve tolerance and quality of life for bladder cancer patients undergoing intravesical therapy.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.
* 3. History of prior chemotherapy: Patients who have received perfusion therapy prior to this study.
* 4. History of other malignant tumors: Patients with a history of other malignant tumors.
* 5. Pregnancy or lactation: Female patients who are pregnant or lactating.
* 6. Psychiatric illness: Patients with a history of severe psychiatric illness or currently receiving treatment for psychiatric illness.
* 7. Poor study compliance: Patients who believe that they are unable to complete the entire trial process as required by the study.
* 8. Other: Other conditions that the investigator considers unsuitable to participate in this study.

Primary outcomes:
measure: The degree of relief from bladder irritation symptoms.
timeFrame: From the start to the end of bladder instillation therapy，Monthly follow-up visits are continued until the end of perfusion therapy and last approximately 1 year
measure: Incidence of systemic adverse reactions
timeFrame: From the start to the end of bladder instillation therapy，Monthly follow-up visits are continued until the end of perfusion therapy and last approximately 1 year
measure: Incidence of Hematuria
timeFrame: From the start to the end of bladder instillation therapy，Monthly follow-up visits are continued until the end of perfusion therapy and last approximately 1 year
measure: Incidence of urinary tract infection
timeFrame: From the start to the end of bladder instillation therapy，Monthly follow-up visits are continued until the end of perfusion therapy and last approximately 1 year
Secondary outcomes:
measure: Quality of life score
timeFrame: From the start to the end of bladder instillation therapy，Monthly follow-up visits are continued until the end of perfusion therapy and last approximately 1 year
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: weiqiang Jing, PhD
role: STUDY_CHAIR
References: