Heart-rate variability biofeedback for bladder cancer patients
A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma
This study is testing if heart-rate variability biofeedback can help bladder cancer patients feel less stressed and improve their quality of life while they receive chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Comenius University Academic / other |
| Drugs / interventions | chemotherapy, Methotrexate, Doxorubicin |
| Locations | 1 site (Bratislava) |
| Trial ID | NCT06269536 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of heart-rate variability biofeedback intervention (HRV BI) in patients with muscle-infiltrating bladder carcinoma (MIBC) undergoing neoadjuvant chemotherapy. Participants will receive standard chemotherapy treatment and will also engage in HRV BI training sessions to learn techniques for reducing stress and improving quality of life. The study will assess various outcomes, including inflammation, quality of life, cognitive functions, and treatment results over a period of 36 months. A total of 50 subjects will be enrolled to compare the effects of HRV BI alongside standard care versus standard care alone.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with muscle-infiltrating urothelial bladder carcinoma who have not received prior chemotherapy.
Not a fit: Patients with diabetes mellitus and symptomatic neuropathy, or those on certain medications like antiarrhythmics or opiates, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance the quality of life and treatment outcomes for bladder cancer patients undergoing chemotherapy.
How similar studies have performed: While the specific combination of HRV biofeedback and chemotherapy in bladder cancer is novel, similar approaches in other cancer types have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Patients older than 18 years. 2. Evidence of muscle-infiltrating urothelial bladder carcinoma (including variants) by biopsy. 3. No prior chemotherapy. 4. No previous malignancy, except for basal-cell carcinoma of the skin within last 5 years. 5. Adequate renal functions: measured or calculated (by Cockcroft formula) creatinine clearance \> 60 ml/min. 6. Absolute granulocytes count 1,500/mm3 or higher, platelets 100,000/mm3 or higher, bilirubin 1.5x the upper limit of normal value and lower. 7. Adequate liver functions. 8. Basic computer skills. 9. Signed informed consent. Exclusion criteria: 1. Diabetes mellitus with symptomatic neuropathy. 2. Using antiarrhythmic drugs, opiates and/or antidepressants. 3. Implanted permanent pacemaker (PPM). 4. Human Immunodeficiency Virus (HIV) infection. 5. Not fitting inclusion criteria.
Where this trial is running
Bratislava
- National Cancer Institute — Bratislava, Slovakia (Recruiting)
Study contacts
- Principal investigator: Patrik Palacka — Faculty of Medicine, Comenius University in Bratislava
- Study coordinator: Luba Hunáková
- Email: luba.hunakova@fmed.uniba.sk
- Phone: +421290119943
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.