Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer

NCT06281145 | Recruiting

• 1 other identifier: RSV-SK001/UC-SK004/OUSA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer; Colon Cancer

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Secondary endpoint - Pathologic Complete Response (pCR) and Residual Cancer Burden (RCB) rate in cohort A

  36 months

• Secondary endpoint - Relapse-free Survival (RFS)

  60 months

• Secondary endpoint - Overall survival (OS)

  96 months

• Secondary endpoint - Serious Adverse Events (SAE)

  36 months

Study Arms (2)

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

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

Interventions

Heart-rate variability biofeedback intervention BEHAVIORAL

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

Standard of care + HRV biofeedback intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

St. Elizabeth Cancer Institute

Bratislava, 81250, Slovakia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Inflammation; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Luba Hunáková

CONTACT

00421290119943; mailto:luba.hunakova@fmed.uniba.sk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study consists of two cohorts (breasts cancer and colorectal cancer) with two arms SOC + intervention vs SOC alone.

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2029
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

SL (1)