NCT06281145Recruiting
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 · Last updated 28 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 20 Feb 2024
- Start date
- 15 Mar 2024
- Primary completion date
- 15 Mar 2027
- Lead sponsor
- Comenius University
- Diseases
- Colorectal cancer
- NCT number
- NCT06281145
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 15 Mar 2024 to the primary completion date, 15 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous chemotherapy.
- 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.
Other illness
- Previous malignancy, except for basal-cell carcinoma of the skin within last 5 years.
- Patients with know primary immunodeficiency and patients infected by the Human Immunodeficiency Virus (HIV).
- Patients with diabetes mellitus, cardiac arrhythmia, cardiac pacemaker implant.
Other
- Patients who do not fit inclusion criteria.
Who the study is looking for
- 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 renal functions: measured or calculated (by Cockcroft formula) creatinine clearance \> 60 ml/min.
- Absolute granulocytes count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5x the upper limit of normal value.
- Adequate liver functions defined by AST (Aspartate aminotransferase) and ALT (Alanine transaminase) ≤ 3xUNL (upper normal of limit).
- Basic computer skills of patient or his family member.
- Signed informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Elizabeth Cancer Institute Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.