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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care + HRV biofeedback intervention | Experimental | Experimental: Heart-rate variability (HRV) biofeedback intervention + standard of care Deep paced breathing with the HRV monitoring performed three times a day for seven minutes during three months with standard of care. Cohort A- breast cancer, Cohort B- colon cancer |
|
| Standard of care | No Intervention | Cohort A- neoadjuvant chemotherapy +/- targeted therapy +/- immunotherapy defined standard of care in current European Society For Medical Oncology (ESMO) guideline in the defined disease subtype Cohort B- adjuvant chemotherapy +/- targeted therapy +/- immunotherapy defined standard of care in current ESMO guideline in the defined disease subtype |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart-rate variability biofeedback intervention | Behavioral | Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 %). | 36 months |
| 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. | 36 months |
| 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. | 36 months |
| 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). | 36 months |
| Primary endpoint- sleep quality | The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on sleep quality measured by both actigraphy and self-report data. The main variables are total time spent sleeping (in hours and minutes), and sleep efficiency (proportion of time spent sleeping vs. time spent in bed trying to sleep). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luba Hunáková | Contact | 00421290119943 | mailto:luba.hunakova@fmed.uniba.sk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Elizabeth Cancer Institute | Recruiting | Bratislava | 81250 | Slovakia |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| D007249 | Inflammation |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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The study consists of two cohorts (breasts cancer and colorectal cancer) with two arms SOC + intervention vs SOC alone.
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| 36 months |
| Primary endpoint - heart rate variability (HRV) | Effect of HRV biofeedback training on HRV indexed by the root mean square of successive differences between heartbeats (RMSSD) in ms. | 36 months |
| Primary endpoint - Working memory | The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on working memory measured by digit span test score (the number of remembered digits in the longest passed sequence), for both forward and backward condition. | 36 months |
| 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. | 60 months |
| 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. | 96 months |
| 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. | 36 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |