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Recruiting NCT06281145

Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer

No phase Interventional Breast Cancer Colon Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Heart-rate variability biofeedback intervention.
Who it may be relevant to
Registry conditions: Breast Cancer, Colon Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovakia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Heart-rate variability biofeedback intervention
    Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months

Primary outcome measures

  • Primary endpoint - inflammation [Time frame: 36 months]
  • Primary endpoint - QoL [Time frame: 36 months]
  • Primary endpoint - executive functions [Time frame: 36 months]
  • Primary endpoint- salivary cortisol slopes [Time frame: 36 months]
  • Primary endpoint- sleep quality [Time frame: 36 months]
  • Primary endpoint - heart rate variability (HRV) [Time frame: 36 months]
  • Primary endpoint - Working memory [Time frame: 36 months]
Secondary outcome measures (4)
  • Secondary endpoint - Pathologic Complete Response (pCR) and Residual Cancer Burden (RCB) rate in cohort A [Time frame: 36 months]
  • Secondary endpoint - Relapse-free Survival (RFS) [Time frame: 60 months]
  • Secondary endpoint - Overall survival (OS) [Time frame: 96 months]
  • Secondary endpoint - Serious Adverse Events (SAE) [Time frame: 36 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Previous chemotherapy.
  • 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).
  • 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.
  • Patients with diabetes mellitus, cardiac arrhythmia, cardiac pacemaker implant.
  • Patients who do not fit inclusion criteria.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Slovakia · 1 center
  • St. Elizabeth Cancer Institute — Bratislava

Identifiers

NCT: NCT06281145 · RSV-SK001/UC-SK004/OUSA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗