NCT06281145

Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer

A Study on Therapeutic Potential of Stress-Reducing Intervention in Patients With Solid Tumors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Comenius University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a prospective, interventional, clinical study with in 2 cohorts. Target of subjects is 50 per cohort and an anticipated total duration of 36 months. Participants will undergo 4 sessions of HRV BI with the trainer where they will learn about the prognostic role of the vagal nerve in cancer and in reducing distress and pain, and how to perform deep paced breathing with the HRV monitoring. They will perform the training daily (3-times, minimum 7 minutes each) at home with the online control for 3 months. Researchers will compare the effect of addition of 3-months training of HRV BI to SOC on inflammation, HRV, quality of life (QoL), cognitive functions, salivary cortisol slopes, sleep quality and treatment outcomes of patients with colorectal and breast cancer.

Conditions

• Breast Cancer
• Colon Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Heart-rate variability biofeedback intervention	Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months

Timeline

• Start date: 2024-03-15
• Primary completion: 2027-03-15
• Completion: 2029-03-15
• First posted: 2024-02-28
• Last updated: 2024-02-28

Locations

1 site across 1 country: Slovakia