Urinary Bladder NeoplasmsNCT06880939
Antarctic Krill Oil Functional Food Mitigates Bladder Cancer Treatment Side Effects
A study testing Krill Oil Functional Food and Olive Oil in people with Urinary Bladder Neoplasms, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- Krill Oil Functional Food and Olive Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2025to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
weiqiang Jing, PhD, 0086-13256102995, wjing1@sdu.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- Krill Oil Functional Food, Olive Oil
- Keywords
- Bladder Cancer, Krill Oil, Intravesical Therapy, Adverse Effects, Randomized Controlled Trial
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill Oil Functional FoodDietary 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 OilDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start15 Jul 2025 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Shandong Provincial Hospital
- Responsible party
- Sponsor
- Investigators
- weiqiang Jing, PhD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880939
- Sponsor's protocol ID
- KYLL-202412-011-1
- Status last verified
- Jul 2025
- First submitted
- 11 Mar 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06880939
- Acronym / sponsor ID
- KYLL-202412-011-1
- Conditions
- Urinary Bladder Neoplasms
- Keywords
- Bladder Cancer, Krill Oil, Intravesical Therapy, Adverse Effects, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Shandong Provincial Hospital
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Krill Oil Functional Food Group | Experimental | Dietary Supplement: Krill Oil Functional FoodDosage: 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. |
| Olive Oil Group | Placebo comparator | Dietary Supplement: Olive OilIntervention: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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Krill Oil Functional FoodTake 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. | Dietary supplement | Krill Oil Functional Food Group |
| Olive OilInstead 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. | Dietary supplement | Olive Oil Group |
Primary outcome
The degree of relief from bladder irritation symptoms.
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
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
Incidence of systemic adverse reactions
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
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.
Incidence of Hematuria
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
Record and compare the occurrence of hematuria in the experimental group and the control group during and after treatment.
Incidence of urinary tract infection
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
Assess the frequency of urinary tract infections through routine urinalysis, urine culture, and symptom monitoring.
1 secondary outcome
Quality of life score
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
weiqiang Jing, PhD study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Krill Oil Functional Food and Olive Oil in people with Urinary Bladder Neoplasms, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact weiqiang Jing, PhD (0086-13256102995, wjing1@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of relief from bladder irritation symptoms. (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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.