Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer

NCT ID: NCT06281145

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2029-03-15

Brief 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. 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.

Conditions

Breast Cancer; Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Heart-rate variability biofeedback intervention

Intervention Type: BEHAVIORAL

Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Heart-rate variability biofeedback intervention

Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Comenius University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Elizabeth Cancer Institute

Bratislava, , Slovakia

Site Status: RECRUITING

Countries

Slovakia

Central Contacts

Luba Hunáková

Role: CONTACT

mailto:luba.hunakova@fmed.uniba.sk

00421290119943

Facility Contacts

Bela Mrinakova, MD

Role: primary

bela.mrinakova@ousa.sk

00421232249111

Miriam Hancinova, MD

Role: backup

miriam.hancinova@ousa.sk

00421232249111

Other Identifiers

RSV-SK001/UC-SK004/OUSA

Identifier Type: -

Identifier Source: org_study_id