Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer (SRI-BrCa_CRC)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Colon Cancer
• Intervention / Treatment: Behavioral: Heart-rate variability biofeedback intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luba Hunáková; Phone Number: 00421290119943; Email: mailto:luba.hunakova@fmed.uniba.sk

Study Locations

• Slovakia
  • Bratislava, Slovakia, 81250
    • Recruiting
    • St. Elizabeth Cancer Institute
    • Principal Investigator: Bela Mrinakova
    • Contact: Bela Mrinakova, MD; Phone Number: 00421232249111; Email: bela.mrinakova@ousa.sk
    • Contact: Miriam Hancinova, MD; Phone Number: 00421232249111; Email: miriam.hancinova@ousa.sk
    • Sub-Investigator: Miriam Hancinova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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 Human Immunodeficiency Virus (HIV).
4. 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.
5. Patients with diabetes mellitus, cardiac arrhythmia, cardiac pacemaker implant.
6. Patients who do not fit inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard of care + HRV biofeedback intervention; 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	Behavioral: Heart-rate variability biofeedback intervention; Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months
No Intervention: Standard of care; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).	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 Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Comenius University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2029

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Inflammation; Telemedicine; Quality of Life; Autonomic Nervous System; Stress; Sleep Quality; Standard of Care; Colon Cancer; Neoadjuvant Chemotherapy; Circadian rhythms; Invasive Breast Cancer; Heart-Rate Variability
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Breast Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Breast Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: RSV-SK001/UC-SK004/OUSA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No