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Antarctic Krill Oil Functional Food Mitigates Bladder Cancer Treatment Side Effects

ConditionUrinary Bladder Neoplasms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Krill Oil Functional Food GroupExperimental treatment 1 intervention
Group B: Olive Oil GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
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
2

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.

Time frame
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
3

Incidence of Hematuria

Record and compare the occurrence of hematuria in the experimental group and the control group during and after treatment.

Time frame
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
4

Incidence of urinary tract infection

Assess the frequency of urinary tract infections through routine urinalysis, urine culture, and symptom monitoring.

Time frame
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

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).

Time frame
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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Hospital of Shandong University

Lead sponsor

The Affiliated Hospital of Qingdao University

Collaborator

Shandong Provincial Hospital

Collaborator

Source ClinicalTrials.gov

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