Heart-rate variability biofeedback for cancer patients
A Study on Therapeutic Potential of Stress-Reducing Intervention in Patients With Solid Tumors
This study is testing whether heart-rate variability biofeedback can help improve the well-being and treatment outcomes for breast and colon cancer patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Comenius University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bratislava) |
| Trial ID | NCT06281145 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with confirmed breast cancer needing neoadjuvant treatment or colon cancer patients post-curative surgery.
Not a fit: Patients with previous chemotherapy or other malignancies, as well as those with certain health conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance the quality of life and treatment outcomes for patients with breast and colon cancer.
How similar studies have performed: Other studies have shown promising results with similar biofeedback approaches, indicating potential for success in this intervention.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bratislava
- St. Elizabeth Cancer Institute — Bratislava, Slovakia (Recruiting)
Study contacts
- Study coordinator: Luba Hunáková
- Email: mailto:luba.hunakova@fmed.uniba.sk
- Phone: 00421290119943
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.