Clinical trial NCT06281145: Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer
Official title: A Study on Therapeutic Potential of Stress-Reducing Intervention in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Colon Cancer
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
Lead sponsor: Comenius University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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.

Primary outcomes:
measure: Primary endpoint - inflammation
timeFrame: 36 months
measure: Primary endpoint - QoL
timeFrame: 36 months
measure: Primary endpoint - executive functions
timeFrame: 36 months
measure: Primary endpoint- salivary cortisol slopes
timeFrame: 36 months
measure: Primary endpoint- sleep quality
timeFrame: 36 months
measure: Primary endpoint - heart rate variability (HRV)
timeFrame: 36 months
measure: Primary endpoint - Working memory
timeFrame: 36 months
Secondary outcomes:
measure: Secondary endpoint - Pathologic Complete Response (pCR) and Residual Cancer Burden (RCB) rate in cohort A
timeFrame: 36 months
measure: Secondary endpoint - Relapse-free Survival (RFS)
timeFrame: 60 months
measure: Secondary endpoint - Overall survival (OS)
timeFrame: 96 months
measure: Secondary endpoint - Serious Adverse Events (SAE)
timeFrame: 36 months
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: St. Elizabeth Cancer Institute
Study officials:
References: