Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer
Recruiting · NCT06281145 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Heart-rate variability biofeedback intervention
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- Previous chemotherapy.
- 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).
- 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.
- Patients with diabetes mellitus, cardiac arrhythmia, cardiac pacemaker implant.
- Patients who do not fit inclusion criteria.
Where it is running
1 location listed.
- St. Elizabeth Cancer Institute - Bratislava, Slovakia