Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorComenius University
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Heart-rate variability biofeedback intervention
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov