Clinical trial · Interventional
Use of Heart Rate Variability (HRV) Biofeedback for Cancer Survivors
Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Cancer Survivors: Pilot Intervention
NCT03692624CI-TRIAL-00043860completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biofeedback | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention 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.
- interventionNames
- Behavioral: Biofeedback
- type
- NO_INTERVENTION
- label
- Control 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.
Primary outcomes (5)
- measure
- Reduced Pain
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDKim DH, Kim JA, Choi YS, Kim SH, Lee JY, Kim YE. Heart rate variability and length of survival in hospice cancer patients. J Korean Med Sci. 2010 Aug;25(8):1140-5. doi: 10.3346/jkms.2010.25.8.1140. Epub 2010 Jul 21. PMID 20676323
- BACKGROUNDHoffmann J, Grimm W, Menz V, Wied M, Sprenger A, Arnold R, Maisch B. Prognostic value of heart rate variability analysis in patients with carcinoid syndrome. Digestion. 2001;63(1):35-42. doi: 10.1159/000051870. PMID 11173898
- BACKGROUNDde Miguel Sanchez C, Elustondo SG, Estirado A, Sanchez FV, de la Rasilla Cooper CG, Romero AL, Otero A, Olmos LG. Palliative performance status, heart rate and respiratory rate as predictive factors of survival time in terminally ill cancer patients. J Pain Symptom Manage. 2006 Jun;31(6):485-92. doi: 10.1016/j.jpainsymman.2005.10.007. PMID 16793488
- BACKGROUNDMouton C, Ronson A, Razavi D, Delhaye F, Kupper N, Paesmans M, Moreau M, Nogaret JM, Hendlisz A, Gidron Y. The relationship between heart rate variability and time-course of carcinoembryonic antigen in colorectal cancer. Auton Neurosci. 2012 Jan 26;166(1-2):96-9. doi: 10.1016/j.autneu.2011.10.002. Epub 2011 Nov 9. PMID 22070982
- BACKGROUNDAppelhans BM, Luecken LJ. Heart rate variability and pain: associations of two interrelated homeostatic processes. Biol Psychol. 2008 Feb;77(2):174-82. doi: 10.1016/j.biopsycho.2007.10.004. Epub 2007 Oct 12. PMID 18023960
- BACKGROUNDKapitza KP, Passie T, Bernateck M, Karst M. First non-contingent respiratory biofeedback placebo versus contingent biofeedback in patients with chronic low back pain: a randomized, controlled, double-blind trial. Appl Psychophysiol Biofeedback. 2010 Sep;35(3):207-17. doi: 10.1007/s10484-010-9130-1. PMID 20237953
- BACKGROUNDBerry ME, Chapple IT, Ginsberg JP, Gleichauf KJ, Meyer JA, Nagpal ML. Non-pharmacological Intervention for Chronic Pain in Veterans: A Pilot Study of Heart Rate Variability Biofeedback. Glob Adv Health Med. 2014 Mar;3(2):28-33. doi: 10.7453/gahmj.2013.075.