Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorComenius University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Heart-rate variability biofeedback intervention
BehavioralDaily deep paced breathing 3-times (minimum 7 minutes each) for 3 months
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Standard of care + HRV biofeedback interventionExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Primary endpoint - inflammation
he effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on inflammation (IL-6, Tumor necrosis factor α, IL-10 from peripheral blood sample in pg/ml and tumour infiltrating lymphocytes (TIL) in %).
Time frame
36 months2
Primary endpoint - QoL
Effect of HRV biofeedback training on quality of life (HRV biofeedback + SOC, vs. The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on EORTC-QLQ-C30 (version 3) score (QLQ- Quality Life Questionnaire). The EORTC-QLQ-C30 has 30 items divided into five functional scales (physical, role, cognitive, emotional, and social), and three symptom scales (fatigue, pain, and nausea and vomiting). The score for each scale as well as the sum score for the whole instrument is standardized to values 0 to 100, with a higher score meaning a worse outcome.
Time frame
36 months3
Primary endpoint - executive functions
Effect of HRV biofeedback training on executive functions (HRV biofeedback + SOC, vs. SOC alone) measured by Stroop task mean response time for color-word condition.
Time frame
36 months4
Primary endpoint- salivary cortisol slopes
The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on salivary cortisol slopes (difference between bedtime and awakening saliva cortisol concentration in ng/ml).
Time frame
36 monthsSecondary outcomes
1
Secondary endpoint - Pathologic Complete Response (pCR) and Residual Cancer Burden (RCB) rate in cohort A
The effect of 3-month heart rate variability (HRV)biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on pCR rate evaluated pathologically in surgical specimen after neoadjuvant therapy, value pCR, RCB I, RCB II, RCB III.
Time frame
36 months2
Secondary endpoint - Relapse-free Survival (RFS)
The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on RFS for cohort A and B measured in months from the day of curative surgery.
Time frame
60 months3
Secondary endpoint - Overall survival (OS)
The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on OS for cohort A and B measured in months from the day of curative surgery.
Time frame
96 months4
Secondary endpoint - Serious Adverse Events (SAE)
The effect of 3-months heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on serious adverse events (SAEs) of chemotherapy.
Time frame
36 monthsSponsors and contacts
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Source ClinicalTrials.gov