Tests a breathing-based stress intervention in people with breast or colon cancer
Tests heart-rate biofeedback training alongside standard care in adults with breast or colon cancer.
Plain-language title generated from the registry record
Registry title: Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer
Key facts
- Where
- Bratislava, SlovakiaSee the site
Where in Slovakia
- St. Elizabeth Cancer InstituteBratislava, SlovakiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Comenius University
- Trial code
- NCT06281145
- Record updated
- 28 February 2024
- Original description
The goal of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in 2 cohorts of patients. Cohort A will evaluate the effect of the addition of HRV BI in patients with breast cancer treated in the neoadjuvant setting (vs. standard of care alone, SOC) followed by local therapy (surgery +/-radiotherapy). Cohort B will evaluate the effect of the addition of HRV BI in patients with colon cancer after surgery in the adjuvant setting (vs. standard of care alone, SOC).Read full original descriptionShow less
A Study on Therapeutic Potential of Stress-Reducing Intervention in Patients With Solid Tumors
The goal of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in 2 cohorts of patients. Cohort A will evaluate the effect of the addition of HRV BI in patients with breast cancer treated in the neoadjuvant setting (vs. standard of care alone, SOC) followed by local therapy (surgery +/-radiotherapy). Cohort B will evaluate the effect of the addition of HRV BI in patients with colon cancer after surgery in the adjuvant setting (vs. standard of care alone, SOC).
Inclusion: Patients older than 18 years; Pathologically confirmed breast cancer indicated for neoadjuvant systemic treatment or colon cancer after curative surgery indicated for adjuvant systemic treatment; Adequate renal functions: measured or calculated (by Cockcroft formula) creatinine clearance > 60 ml/min; Absolute granulocytes count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5x the upper limit of normal value; Adequate liver functions defined by AST (Aspartate aminotransferase) and ALT (Alanine transaminase) ≤ 3xUNL (upper normal of limit); Basic computer skills of patient or his family member; Signed informed consent.
Exclusion: Previous chemotherapy; Patient receiving long term corticosteroid treatment, anti-arrhythmic drugs and opioids who can not withdraw the treatment for the period of application of the heart rate variability (HRV) biofeedback training; Previous malignancy, except for basal-cell carcinoma of the skin within last 5 years; Patients with know primary immunodeficiency and patients infected by the Human Immunodeficiency Virus (HIV); Patients with diabetes mellitus, cardiac arrhythmia, cardiac pacemaker implant; Patients who do not fit inclusion criteria.