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Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer

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).

ClinicalTrials.gov IDNCT06281145

PhaseNA

Enrollment100

SponsorComenius University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer, Colon Cancer

About this study

Interventions

Behavioral: Heart-rate variability biofeedback intervention — Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months

Primary outcomes

Primary endpoint - inflammation (36 months)
Primary endpoint - QoL (36 months)
Primary endpoint - executive functions (36 months)
Primary endpoint- salivary cortisol slopes (36 months)
Primary endpoint- sleep quality (36 months)
Primary endpoint - heart rate variability (HRV) (36 months)
Primary endpoint - Working memory (36 months)

Eligibility information

Inclusion Criteria: 1. Patients older than 18 years. 2. Pathologically confirmed breast cancer indicated for neoadjuvant systemic treatment or colon cancer after curative surgery indicated for adjuvant systemic treatment. 3. Adequate renal functions: measured or calculated (by Cockcroft formula) creatinine clearance \> 60 ml/min. 4. Absolute granulocytes count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5x the upper limit of normal value. 5. Adequate liver functions defined by AST (Aspartate aminotransferase) and ALT (Alanine transaminase) ≤ 3xUNL (upper normal of limit). 6. Basic computer skills of patient or his family member. 7. Signed informed consent. Exclusion Criteria: 1. Previous chemotherapy. 2. Previous malignancy, except for basal-cell carcinoma of the skin within last 5 years. 3. Patients with know primary immunodeficiency and patients infected by the Human Immunodeficiency Virus (HIV). 4. 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. 5. Patients with diabetes mellitus, cardiac arrhythmia, cardiac pacemaker implant. 6. Patients who do not fit inclusion criteria.

Study locations

St. Elizabeth Cancer Institute, Bratislava, 81250 Slovakia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.