Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer

Last updated: February 20, 2024
Sponsor: Comenius University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Colorectal Cancer

Breast Cancer

Treatment

Heart-rate variability biofeedback intervention

Clinical Study ID

NCT06281145
RSV-SK001/UC-SK004/OUSA
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients older than 18 years.
  2. Pathologically confirmed breast cancer indicated for neoadjuvant systemic treatment orcolon cancer after curative surgery indicated for adjuvant systemic treatment.
  3. Adequate renal functions: measured or calculated (by Cockcroft formula) creatinineclearance > 60 ml/min.
  4. Absolute granulocytes count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5x theupper limit of normal value.
  5. Adequate liver functions defined by AST (Aspartate aminotransferase) and ALT (Alaninetransaminase) ≤ 3xUNL (upper normal of limit).
  6. Basic computer skills of patient or his family member.
  7. Signed informed consent.

Exclusion

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 HumanImmunodeficiency Virus (HIV).
  4. Patient receiving long term corticosteroid treatment, anti-arrhythmic drugs andopioids who can not withdraw the treatment for the period of application of the heartrate variability (HRV) biofeedback training.
  5. Patients with diabetes mellitus, cardiac arrhythmia, cardiac pacemaker implant.
  6. Patients who do not fit inclusion criteria.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Heart-rate variability biofeedback intervention
Phase:
Study Start date:
March 15, 2024
Estimated Completion Date:
March 15, 2029

Study 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.

Connect with a study center

  • St. Elizabeth Cancer Institute

    Bratislava, 81250
    Slovakia

    Active - Recruiting

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