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WithdrawnNCT03674450HRVUpdated Apr 7, 2020

Lung Heart Rate Variability

An interventional study of Heart Rate Variability Biofeedback Training in Non Small Cell Lung Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-04-07.

Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Treatment

Why this study was withdrawn
This study never enrolled any subjects. It was terminated due to staffing and technology changes.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study summary

The purpose of this study is to examine the effects of heart-rate variability biofeedback training on lung cancer patients receiving definitive radiation therapy. The target population consists of non-small cell lung cancer (NSCLC) patients receiving 6 weeks of radiation therapy. The study will utilize the Physiolab GP8 heart rate variability and respiration system to collect data as well as several survey instruments to analyze quality of life measures. The goal is to show the HRV training can improve certain QOL measures like anxiety and sleep quality.

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Conditions studied

  • Non Small Cell Lung Cancer

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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

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Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants must be older than 18 years of age
  • Both women and men of all ethnic background are eligible to participate in the study.
  • Must be diagnosed with non-small cell lung cancer and receiving 6 weeks of radiation therapy.
  • Must be available and willing to participate in 4, approximately 1 hour HRV biofeedback treatment sessions.
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Participant is younger than 18 or older than 70
  • Diagnosed with early stage NSCLC
  • Patients who are pregnant
  • Patients with cardiac arrhythmias
  • Patients with Pacemakers
  • Patients taking beta-blockers
  • Patients with any major mental illness, cognitive impairment
  • Incapable of giving informed consent
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Interventional

    Behavioral: Heart Rate Variability Biofeedback Training

Interventions

  • BehavioralHeart Rate Variability Biofeedback Training

    The study will utilize the Physiolab GP8 heart rate variability and respiration system on a laptop computer used solely for the study with the proper security passwords to protect participant information. The equipment consists of two electrocardiogram sensors (one per wrist) attached by sports wrist bands, a respiration monitoring belt placed around the upper abdomen, two galvanic skin conductance sensors attached to the fingertips, and a thermistor sensor attached to one of the finger tips. Participants will perform a series of monitored breathing exercises.

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What researchers measure

Primary outcomes

  1. EORTC QLQ-C30 Questionnaire

    Questionnaire developed to assess the quality of life of cancer patients. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Time frame: 2 years

Secondary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Measure the quality and patterns of sleep in adults. It differentiates from "poor" and "good" sleep quality by measuring seven areas. The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score). Item 10 does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

    Time frame: 2 years

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Study locations

1 site
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
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References and documents

Publications

  • Ancoli-Israel S, Moore PJ, Jones V. The relationship between fatigue and sleep in cancer patients: a review. Eur J Cancer Care (Engl). 2001 Dec;10(4):245-55. doi: 10.1046/j.1365-2354.2001.00263.x. PubMed 11806675 ↗
  • Badger TA, Braden CJ, Mishel MH, Longman A. Depression burden, psychological adjustment, and quality of life in women with breast cancer: patterns over time. Res Nurs Health. 2004 Feb;27(1):19-28. doi: 10.1002/nur.20002. PubMed 14745853 ↗
  • Guo Y, Koshy S, Hui D, Palmer JL, Shin K, Bozkurt M, Yusuf SW. Prognostic Value of Heart Rate Variability in Patients With Cancer. J Clin Neurophysiol. 2015 Dec;32(6):516-20. doi: 10.1097/WNP.0000000000000210. PubMed 26629761 ↗
  • Hassett AL, Radvanski DC, Vaschillo EG, Vaschillo B, Sigal LH, Karavidas MK, Buyske S, Lehrer PM. A pilot study of the efficacy of heart rate variability (HRV) biofeedback in patients with fibromyalgia. Appl Psychophysiol Biofeedback. 2007 Mar;32(1):1-10. doi: 10.1007/s10484-006-9028-0. Epub 2007 Jan 12. PubMed 17219062 ↗
  • Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247. PubMed 18183564 ↗
  • Karavidas MK, Lehrer PM, Vaschillo E, Vaschillo B, Marin H, Buyske S, Malinovsky I, Radvanski D, Hassett A. Preliminary results of an open label study of heart rate variability biofeedback for the treatment of major depression. Appl Psychophysiol Biofeedback. 2007 Mar;32(1):19-30. doi: 10.1007/s10484-006-9029-z. Epub 2007 Mar 1. PubMed 17333315 ↗
  • Liu L, Ancoli-Israel S. Sleep Disturbances in Cancer. Psychiatr Ann. 2008 Sep 1;38(9):627-634. doi: 10.3928/00485713-20080901-01. No abstract available. PubMed 21243092 ↗
  • Reiner R. Integrating a portable biofeedback device into clinical practice for patients with anxiety disorders: results of a pilot study. Appl Psychophysiol Biofeedback. 2008 Mar;33(1):55-61. doi: 10.1007/s10484-007-9046-6. Epub 2008 Feb 20. PubMed 18286369 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03674450
Lead sponsor
Abramson Cancer Center at Penn Medicine
Responsible party
Sponsor
First posted
Sep 17, 2018
Start date
Jan 2, 2019
Primary completion
Apr 11, 2019
Completion
Apr 11, 2019
Last update
Apr 7, 2020

Study contacts

William Levin
principal investigator · Abramson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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