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A Randomized Controlled Trial of a Glutamate-Lowering Diet to Enhance the Efficacy of BCG Instillation Therapy for Basal/Squamous Subtype Bladder Cancer

A Randomized Controlled Trial of a Glutamate-Lowering Diet to Enhance the Efficacy of BCG Instillation Therapy for Basal/Squamous Subtype Bladder Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119968
Enrollment
Unknown
Registered
2026-03-06
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder cancer

Interventions

Intervention Group :Glutamate-Lowering Diet Guidance + Standard BCG Therapy
Control group:Conventional nutrition guidance+standard BCG treatment

Sponsors

Yantai Yuhuangding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years, any gender; 2.Pathologically confirmed high-risk NMIBC (HG Ta, T1 ± CIS) post-TURBT with negative resection margins; 3.Tumor subtype confirmed as non-basal by central laboratory review; 4.BCG perfusion therapy was first received and started within 4-6 weeks after TURBT. 5.ECOG performance status 0-1; 6.Adequate hepatic/renal function:(ALT/AST < 2.5 × ULN,Serum creatinine < 1.5 × ULN); 7.Voluntarily signed informed consent with willingness/adherence to protocol requirements (including diet and follow-up).

Exclusion criteria

Exclusion criteria: 1.Radiologically or pathologically confirmed muscle-invasive bladder cancer (>=T2) or metastatic disease; 2.Tumor histology of basal subtype, sarcomatoid differentiation, or neuroendocrine carcinoma; 3.Active tuberculosis, other severe infectious diseases, or contraindications to BCG instillation; 4.Gastrointestinal disorders severely impairing oral intake/nutrient absorption (e.g., complete bowel obstruction, severe Crohn's disease, short bowel syndrome); 5.Documented history of severe allergy to primary components of the prescribed diet (e.g., specific meats, dairy products); 6.Systemic immunosuppressants or high-dose corticosteroids within 4 weeks prior to enrollment; 7.Pregnancy, lactation, or planned pregnancy during the study period; 8.Concurrent participation in other interventional trials that may confound study results.

Design outcomes

Primary

MeasureTime frame
Recurrence rates;

Secondary

MeasureTime frame
Trends in urinary glutamate and serum glutamate levels;Recurrence-Free Survival (RFS) and Progression-Free Survival (PFS);Disease Specific Survival;

Countries

China

Contacts

Public ContactChunhua Lin

Yantai Yuhuangding Hospital

Chunhua.lin@qdu.edu.cn+86 535 6691999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026