Antarctic Krill Oil Functional Food Mitigates Bladder Cancer Treatment Side Effects

NCT06880939 | Not Yet Recruiting

• 1 other identifier: KYLL-202412-011-1
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Bladder Neoplasms

Keywords

Bladder Cancer; Krill Oil; Intravesical Therapy; Adverse Effects; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Quality of life score

  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

Study Arms (2)

Krill Oil Functional Food Group

EXPERIMENTAL

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

Olive Oil Group

PLACEBO COMPARATOR

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

Interventions

Krill Oil Functional Food DIETARY_SUPPLEMENT

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.

Krill Oil Functional Food Group

Olive Oil DIETARY_SUPPLEMENT

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.

Olive Oil Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Diagnosed bladder cancer: The patient needs to be diagnosed with bladder cancer through pathological examination and have undergone bladder cancer surgery.
• \. Planned to receive bladder infusion therapy: Patients need to plan to receive bladder infusion therapy after surgery and agree to participate in the study.
• \. Age range: 18 to 75 years old.
• \. 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.
• \. Signed informed consent: The patient understands the content of the study and voluntarily signs the informed consent.

You may not qualify if:

• \. Serious comorbidities: including but not limited to heart disease, severe liver and kidney insufficiency, uncontrolled hypertension, diabetes, etc.
• \. History of allergies: Patients with a known history of allergy to krill oil or perfusion drug components.
• \. History of prior chemotherapy: Patients who have received perfusion therapy prior to this study.
• \. History of other malignant tumors: Patients with a history of other malignant tumors.
• \. Pregnancy or lactation: Female patients who are pregnant or lactating.
• \. Psychiatric illness: Patients with a history of severe psychiatric illness or currently receiving treatment for psychiatric illness.
• \. Poor study compliance: Patients who believe that they are unable to complete the entire trial process as required by the study.
• \. Other: Other conditions that the investigator considers unsuitable to participate in this study.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• The Affiliated Hospital of Qingdao University: collaborator
• Shandong Provincial Hospital: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• weiqiang Jing, PhD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

weiqiang Jing, PhD

CONTACT

0086-13256102995; wjing1@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the participants and investigators are unaware of the group assignments, and the entire trial is arranged and controlled by the study designer.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 18, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)