NCT06281145 Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer
| NCT ID | NCT06281145 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Comenius University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-15 |
| Primary Completion | 2027-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-03-15 with a primary completion date of 2027-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06281145 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06281145 currently recruiting?
Yes, NCT06281145 is actively recruiting participants. Contact the research team at mailto:luba.hunakova@fmed.uniba.sk for enrollment information.
Where is the NCT06281145 trial being conducted?
This trial is being conducted at Bratislava, Slovakia.
Who is sponsoring the NCT06281145 clinical trial?
NCT06281145 is sponsored by Comenius University. The trial plans to enroll 100 participants.
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