Heart-rate variability biofeedback for cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to evaluate the effectiveness of heart-rate variability biofeedback intervention (HRV BI) in two cohorts of patients with breast and colon cancer. Cohort A will assess the impact of HRV BI in breast cancer patients undergoing neoadjuvant treatment, while Cohort B will focus on colon cancer patients post-surgery in the adjuvant setting. Participants will receive four training sessions and will practice daily HRV techniques at home for three months. The study will measure outcomes related to inflammation, quality of life, cognitive functions, and treatment results.

Why it matters

Who can join: the full rules

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.

Where it's running

• St. Elizabeth Cancer Institute
  Bratislava, Slovakia Recruiting

Study contacts

• Study coordinator: Luba Hunáková
• Email: mailto:luba.hunakova@fmed.uniba.sk
• Phone: 00421290119943

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.