Breast CancerSRI-BrCa_CRCNCT06281145
Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer
A study testing Heart-rate variability biofeedback intervention in people with Breast Cancer and Colon Cancer, run by Comenius University at 1 site in Slovakia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colon Cancer
- What is being tested?
- Heart-rate variability biofeedback intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSlovakia
- Study dates
- 15 Mar 2024to 15 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site, 1 recruiting
- Recruiting
St. Elizabeth Cancer Institute
Bratislava, 81250
Bela Mrinakova, MD, 00421232249111, bela.mrinakova@ousa.sk
Miriam Hancinova, MD, 00421232249111, miriam.hancinova@ousa.sk
About this study
Official title: 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).
Read the 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.
- Conditions
- Breast Cancer, Colon Cancer
- Being tested
- Heart-rate variability biofeedback intervention
- Keywords
- Colon Cancer, Invasive Breast Cancer, Neoadjuvant Chemotherapy, Standard of Care, Inflammation, Stress, Telemedicine, Circadian rhythms, Sleep Quality, Quality of Life, Autonomic Nervous System, Heart-Rate Variability
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Inflammation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart-rate variability biofeedback interventionBehavioural
Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Heart-rate variability biofeedback intervention |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 36 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 Mar 2024 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two cohorts (breasts cancer and colorectal cancer) with two arms SOC + intervention vs SOC alone.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281145
- Sponsor's protocol ID
- RSV-SK001/UC-SK004/OUSA
- Acronym
- SRI-BrCa_CRC
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Therapeutic Potential of Stress-Reducing Intervention in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT06281145
- Acronym / sponsor ID
- SRI-BrCa_CRC / RSV-SK001/UC-SK004/OUSA
- Conditions
- Breast Cancer, Colon Cancer
- Keywords
- Colon Cancer, Invasive Breast Cancer, Neoadjuvant Chemotherapy, Standard of Care, Inflammation, Stress, Telemedicine, Circadian rhythms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2029 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study consists of two cohorts (breasts cancer and colorectal cancer) with two arms SOC + intervention vs SOC alone.
| Arm | Type | Receives |
|---|---|---|
| Standard of care + HRV biofeedback intervention | Experimental | Behavioral: Heart-rate variability biofeedback interventionExperimental: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart-rate variability biofeedback interventionDaily deep paced breathing 3-times (minimum 7 minutes each) for 3 months | Behavioural | Standard of care + HRV biofeedback intervention |
Primary outcome
Primary endpoint - inflammation
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 %).
Primary endpoint - QoL
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.
Primary endpoint - executive functions
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.
Primary endpoint- salivary cortisol slopes
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).
Primary endpoint- sleep quality
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).
Primary endpoint - heart rate variability (HRV)
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.
Primary endpoint - Working memory
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart-rate variability biofeedback intervention in people with Breast Cancer and Colon Cancer, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luba Hunáková (00421290119943, mailto:luba.hunakova@fmed.uniba.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint - inflammation (time frame: 36 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.