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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Bladder Neoplasms
• Intervention / Treatment: Dietary supplement: Krill Oil Functional Food; Dietary supplement: Olive Oil

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.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: weiqiang Jing, PhD; Phone Number: 0086-13256102995; Email: wjing1@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Qilu Hospital of Shandong University
      • Contact: weiqiang Jing, PhD; Phone Number: 0086-13256102995; Email: wjing1@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Krill Oil Functional Food Group; Dosage: 2 g of krill oil per day, orally administered. Specification: Krill oil capsules are provided in 1 g/capsule format. Administration: Take 1 capsule 30 minutes after breakfast and 1 capsule 30 minutes after dinner. Note: The Antarctic krill oil functional food used in this study is produced and supplied by Jinan Jiyuan Biotechnology Co., Ltd. Its main components include phospholipids, DHA, EPA, and astaxanthin. Duration: Administration begins on the day of the first bladder instillation treatment and continues until the day of the last bladder instillation treatment. Form: Capsule form for convenient oral administration.	Dietary supplement: 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.
Placebo Comparator: Olive Oil Group; Intervention:Participants will not orally consume krill oil. Instead, they will receive placebo capsules that are visually identical to krill oil capsules.The placebo capsules contain olive oil.Each capsule is 1g in size. Dosage and Administration:Take 1 capsule after breakfast and 1 capsule after dinner, within 30 minutes of each meal. Duration:The intervention will begin on the day of the first bladder instillation treatment.It will continue until the day of the last bladder instillation treatment.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of relief from bladder irritation symptoms.	To evaluate whether krill oil can significantly alleviate symptoms such as urgency, frequency, and pain during urination, a symptom scoring system (e.g., the International Prostate Symptom Score, IPSS) can be used	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
Incidence of systemic adverse reactions	Record and compare the systemic adverse reactions (such as nausea, fatigue, fever, rash, etc.) between the experimental group and the control group during the treatment period and after the treatment has concluded.	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
Incidence of Hematuria	Record and compare the occurrence of hematuria in the experimental group and the control group during and after treatment.	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
Incidence of urinary tract infection	Assess the frequency of urinary tract infections through routine urinalysis, urine culture, and symptom monitoring.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score	The quality of life of study participants during and after treatment was assessed using the Quality of Life Scale (Qol) The quality of life of study participants during and after treatment was assessed using the Quality of Life Scale (Qol).	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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: The Affiliated Hospital of Qingdao University; Shandong Provincial Hospital
• Investigators: Study Chair: weiqiang Jing, PhD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 16, 2025
• First Posted (Actual): March 18, 2025

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 20, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Bladder Cancer; Adverse Effects; Krill Oil; Intravesical Therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: KYLL-202412-011-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No