Actively Recruiting
Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer
Led by Comenius University · Updated on 2024-02-28
100
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
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).
CONDITIONS
Official Title
Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 kidney function with creatinine clearance over 60 ml/min.
- Absolute granulocyte count of at least 1,500/mm3, platelet count at least 100,000/mm3, and bilirubin less than or equal to 1.5 times the upper normal limit.
- Adequate liver function with AST and ALT levels less than or equal to three times the upper normal limit.
- Basic computer skills of the patient or a family member.
- Signed informed consent.
You will not qualify if you...
- Previous chemotherapy treatment.
- Previous cancer except for basal-cell skin cancer within the last 5 years.
- Known primary immunodeficiency or HIV infection.
- Long-term treatment with corticosteroids, anti-arrhythmic drugs, or opioids that cannot be stopped during the HRV biofeedback training.
- Diagnosis of diabetes mellitus, cardiac arrhythmia, or having a cardiac pacemaker.
- Patients who do not meet the inclusion criteria.
AI-Screening
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Trial Site Locations
Total: 1 location
1
St. Elizabeth Cancer Institute
Bratislava, Slovakia, 81250
Actively Recruiting
Research Team
L
Luba Hunáková
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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