Use of Heart Rate Variability (HRV) Biofeedback for Cancer Survivors

Prisma Health-Upstate

Status: Completed

Conditions: Cancer

Treatments: Behavioral: Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT03692624

Pro00042898

Details and patient eligibility

About

Heart rate variability biofeedback (HRV-B) is a complementary, non-pharmacologic therapy that is being tested to see if it can help cancer survivors reduce their symptoms of pain, stress, insomnia, fatigue, or depression. HRV-B is an interactive procedure in which participants relax and breathe regularly while watching the a computer screen. The computer screen provides feedback that helps people increase their heart rate variability.

Full description

Cancer survivors often suffer from prolonged and persistent symptom clusters that can include: pain, stress, depression, fatigue, and insomnia; symptoms that have each been associated with inflammation. The number of cancer survivors in the United States is expected to triple by the year 2030. Thus, there is a compelling need to develop and refine effective methods to promote high quality cancer survivorship. Dysregulation of autonomic function is a key pathophysiological 'common denominator' whereby many cancer-related symptoms likely converge. Heart rate variability (HRV) is a valid, noninvasive measure of autonomic function with established pathological and psychophysiological attributes. Reduced HRV is a known mortality risk factor, and about 80% of advanced cancer patients exhibit autonomic dysregulation. Cancer survivors with reduced HRV have increased mortality risk relative to those with normal HRV. HRV biofeedback (HRV-B) is an interactive procedure whereby patients learn to increase HRV and restore autonomic balance. HRV coherence refers to a state of optimum HRV rhythm that produces physiological entrainment of HRV, respiration, and the baroreflex. With HRV coherence, consecutive inter-beat intervals cycle from maximum to minimum and back to maximum over a period of about 10 seconds, which is associated with increased parasympathetic and decreased sympathetic tone, and a heightened state of well-being including improved affect, cognition, and executive function. Previous research suggests that HRV-B interventions may be useful for reducing symptoms of: chronic pain, anxiety, depression, post-traumatic stress disorder (PTSD), heart disease, and insomnia. HRV-B thus represents a promising complementary, nonpharmacological therapy that merits examination for relief of chronic pain and related symptoms among cancer survivors.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histopathologically confirmed diagnosis of cancer having completed radiation or chemotherapy
• 18 years of age or older
• English literate

Exclusion criteria

• patients receiving concurrent treatment for cancer except hormonal or biologic therapy
• patients with cardiovascular disorders that affect HRV parameters (paroxysmal supraventricular tachycardia, atrial fibrillation, myocardial infarction within 12 months, unstable angina)
• patients receiving medications that affect cardiac rhythm (angiotensin converting enzyme, calcium channel, or beta-adrenergic inhibitors)
• patients with a pacemaker or defibrillator
• patients who have had a heart transplant or by-pass surgery within 1 year
• patients with any active seizure disorder or use of antiseizure or anticonvulsant medication prescribed specifically for seizure disorder
• patients with a pre-existing dementia prior to cancer diagnosis
• patients with a moderate (without good recovery) or severe head injury or stroke in last 6 months
• patients with evidence of active substance abuse or dependence
• patients with a history of any major psychiatric disorder
• patients with a history of brain metastases, primary brain cancer, or altered cognitive abilities
• patients with any use of long acting (extended release) opioid medications

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

34 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Biofeedback. Participants receiving the HRV-B intervention will complete a baseline assessment, a minimum of 4 weeks and up to 6 weekly training sessions (until the criterion of HRV coherence is met), and a final appointment (3-7 days later) where post-training HRV and symptom inventories will be recorded.

Treatment:

Behavioral: Biofeedback

Control Group

No Intervention group

Description:

To control for the laboratory environment or other potential placebo effects, a control group will receive their usual follow-up care for their cancer diagnosis and will complete baseline and post-baseline outcome assessments without any HRV-B training.