St. Elizabeth Cancer Institute
Bratislava, 81250, Slovakia
Location status: Recruiting
Location contact
Bela Mrinakova
PRINCIPAL_INVESTIGATOR
Bela Mrinakova, MD
CONTACT
Miriam Hancinova
SUB_INVESTIGATOR
Miriam Hancinova, MD
CONTACT
NCT Number: NCT06281145
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Bratislava, 81250, Slovakia
Location status: Recruiting
Bela Mrinakova
PRINCIPAL_INVESTIGATOR
Bela Mrinakova, MD
CONTACT
Miriam Hancinova
SUB_INVESTIGATOR
Miriam Hancinova, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months
Time frame: 36 months
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 months
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 months
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 months
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 months
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).
Time frame: 36 months
Effect of HRV biofeedback training on HRV indexed by the root mean square of successive differences between heartbeats (RMSSD) in ms.
Time frame: 36 months
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.
Time frame: 36 months
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: 60 months
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: 96 months
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: 36 months
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.
Contact information is provided by the study sponsor or research team.
Comenius University
Other
A Study on Therapeutic Potential of Stress-Reducing Intervention in Patients With Solid Tumors
Acronym: SRI-BrCa_CRC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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