Clinical trial · Interventional
Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer
A Study on Therapeutic Potential of Stress-Reducing Intervention in Patients With Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Heart-rate variability biofeedback intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Standard of care + HRV biofeedback intervention
- description
- Experimental: Heart-rate variability (HRV) biofeedback intervention + standard of care Deep paced breathing with the HRV monitoring performed three times a day for seven minutes during three months with standard of care. Cohort A- breast cancer, Cohort B- colon cancer
- interventionNames
- Behavioral: Heart-rate variability biofeedback intervention
- type
- NO_INTERVENTION
- label
- Standard of care
- description
- Cohort A- neoadjuvant chemotherapy +/- targeted therapy +/- immunotherapy defined standard of care in current European Society For Medical Oncology (ESMO) guideline in the defined disease subtype Cohort B- adjuvant chemotherapy +/- targeted therapy +/- immunotherapy defined standard of care in current ESMO guideline in the defined disease subtype
Primary outcomes (7)
- measure
- Primary endpoint - inflammation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available