Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer

Trial Title: Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer

NCT ID: NCT06281145

Condition: Breast Cancer
Colon Cancer

Conditions: Official terms:
Breast Neoplasms
Colonic Neoplasms

Conditions: Keywords:
Colon Cancer
Invasive Breast Cancer
Neoadjuvant Chemotherapy
Standard of Care
Inflammation
Stress
Telemedicine
Circadian rhythms
Sleep Quality
Quality of Life
Autonomic Nervous System
Heart-Rate Variability

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: The study consists of two cohorts (breasts cancer and colorectal cancer) with two arms SOC + intervention vs SOC alone.

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Heart-rate variability biofeedback intervention
Description: Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months
Arm group label: Standard of care + HRV biofeedback intervention

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.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: St. Elizabeth Cancer Institute

Address:
City: Bratislava
Zip: 81250
Country: Slovakia

Status: Recruiting

Contact:
Last name: Bela Mrinakova, MD

Phone: 00421232249111
Email: bela.mrinakova@ousa.sk

Contact backup:
Last name: Miriam Hancinova, MD

Phone: 00421232249111
Email: miriam.hancinova@ousa.sk

Investigator:
Last name: Bela Mrinakova
Email: Principal Investigator

Investigator:
Last name: Miriam Hancinova
Email: Sub-Investigator

Start date: March 15, 2024

Completion date: March 15, 2029

Lead sponsor:
Agency: Comenius University
Agency class: Other

Source: Comenius University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06281145