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Breast CarcinomaNCT06456411

Functional Near-Infrared Spectroscopy and Virtual Reality Relaxation Programs for Pain Management in Patients With Cancer

A study testing Functional Near-Infrared Spectroscopy, Questionnaire Administration and Virtual Technology Intervention in people with Breast Carcinoma and Kidney Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study aims to develop objective tools for assessing perceived pain severity in cancer patients and survivors, evaluate the sustained effectiveness of non-pharmacological interventions such as virtual reality in reducing pain and medication use, and create tools for the early detection of neuropathy. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Breast Carcinoma, Kidney Carcinoma, Carcinoma
What is being tested?
Functional Near-Infrared Spectroscopy, Questionnaire Administration and Virtual Technology Intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteUnited States
Study dates
12 Jul 2022to 10 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Cancer pts as well as healthy volunteers) must be over the age of 18
  • Participants in Groups A or C (cancer pts as well as healthy volunteers) need to be able to be in a sedentary posture for approximately 20 minutes
  • Participants in Group B and C: Patient can be in any stage of cancer treatment, such as diagnosis, treatment (surgery, chemotherapy, immunotherapy, radiation), recovery, remission and is experiencing acute pain from treatment or cancer itself. Cancers include but are not limited to: breast, thoracic, lung, kidney, colon, pancreatic, etc.
  • Participants in Group B and C must be free from other forms of chronic pain, e.g., rheumatologic pain, must be free from neurologic illnesses, e.g., stroke, and must have no brain metastases which could interfere with brain functions
  • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
  • Men and women of 40-80 yrs old
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  • Stage I-III lung cancer survivors who have undergone lung resection and developed persistent post-thoracotomy pain (PPTP)
  • Willing to comply with study procedures
  • Be able to remain sedentary for 20 minutes during functional near-infrared spectroscopy (fNIRS) data recording sessions, including 10 minutes each for fNIRS system setup and 10 minutes data recording.
  • Female participants must not be pregnant to participate in this study. During the third trimester, the fetus's brain is significantly developed and may interact with the mother's brain. As this study involves recording brain activity using fNIRS, it is necessary to exclude pregnant individuals to ensure the quality of the research data.
  • Be able to remove any items from their scalp that might block direct contact between the fNIRS optodes and the skin. This includes, but is not limited to, wigs and hijabs.
  • Must be free from other forms of chronic pain, e.g., rheumatologic pain
  • Must be free from neurologic illnesses, e.g., stroke
  • Had no brain metastases which could interfere with brain functions
  • Must understand the investigational nature of the study and sign a written informed consent form approved by the Independent Ethics Committee/Institutional Review Board.
  • Men and women aged 18 yrs and older.
  • Diagnosed with colorectal or pancreatic cancer, scheduled to receive a 14-day cycle of oxaliplatin chemotherapy (oxaliplatin plus infusional fluorouracil regimens). Limiting the study to these patients ensures a more uniform population, reducing variability related to treatment regimens.
  • Be able to remove any items from their scalp that might block direct contact between the skin and fNIRS optodes. This includes, but is not limited to, wigs and hijabs. Furthermore, individuals with metal implants in the skull due to previous surgeries are not eligible to participate.
  • Participants must be willing to comply with study procedures.
  • Must understand the investigational nature of the study and sign a written informed consent form approved by the Independent Ethics Committee/Institutional Review Board.

Who cannot join

  • Unwilling or unable to follow protocol requirements
  • Currently pregnant or planning to become pregnant during the study period
  • FOR GROUP B :
  • Medical condition predisposing to nausea or dizziness.
  • Hypersensitivity to flashing light or motion.
  • stereoscopic vision or severe hearing impairment.
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  • Unwillingness or inability to follow protocol requirements.
  • Individuals with impaired decision-making capacity.
  • Individuals with electronic or metallic implants in the head.
  • Unable to remove any items from their scalp that might block direct contact between the fNIRS optodes and the skin. This includes, but is not limited to, wigs and hijabs
  • Prisoners
  • individuals with hypersensitivity to flashing lights or motion. Rationale: Such hypersensitivities can increase the risk of seizures or severe discomfort when exposed to common elements of VR programs, which frequently include rapid visual and motion stimuli.
  • individuals with impaired stereoscopic vision or severe hearing impairments. Rationale: VR programs often involve moving objects, flashing lights, and immersive soundscapes. Participants must have sufficient vision and hearing to effectively engage with and safely navigate these environments.
  • Currently pregnant or planning to become pregnant during the study period.
  • Unwillingness or inability to follow protocol requirements.
  • individuals with impaired decision-making capacity. Rationale: Participants must be able to provide informed consent and make decisions regarding their continued participation in the study.
  • Prisoners
  • Individuals with electronic or metallic implants in the head, as these implants may obstruct direct contact between the fNIRS optodes and the skin.
  • Patients with medical conditions that predispose them to nausea or dizziness. Rationale: To minimize the risk of cybersickness that may be induced by VR programs.
  • Patients with signs of cancer-related cachexia, specifically those with >15% unintentional weight loss over the past 6 months or a BMI <18 will be excluded to ensure safety and data integrity.
  • Diabetic patients are excluded as they may experience chronic pain differently.
  • Individuals treated with Carboplatin, Cisplatin, taxanes, or other platinum-based therapies should be excluded. These treatments are known to cause peripheral neuropathy, and their inclusion could confound the results. To focus specifically on neuropathy caused by oxaliplatin, patients receiving other neurotoxic chemotherapy agents are excluded.
  • Individuals who underwent other neuropathy-associated chemotherapy treatments will be excluded.
  • Females who are pregnant or plan to become pregnant during the study period will be excluded.
  • Unwillingness or inability to follow protocol requirements.
  • individuals with impaired decision-making capacity. Rationale: Participants must be able to provide informed consent and make decisions regarding their continued participation in the study.
  • Individuals who are not yet adults (younger than 18 years).
  • Prisoners.
  • Individuals with electronic or metallic implants in the head, as these implants may obstruct direct contact between the skin and fNIRS optodes.
  • Pre-existing conditions or comorbidities that could interfere with the study, such as:
  • severe neurological disorders, neurologic illnesses, e.g stroke
  • peripheral neuropathy unrelated to chemotherapy
  • other forms of chronic neuropathy
  • diabetic patients will be excluded as those patients may experience different neuropathy and their reactions might skew the results

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: Real-Time Evaluation of Severity of Perceived Pain in Patients With Cancer by Using Functional Near-Infrared Spectroscopy (fNIRS), and Investigation of Pain Relief Utilizing Virtual Reality Technologies

This study aims to develop objective tools for assessing perceived pain severity in cancer patients and survivors, evaluate the sustained effectiveness of non-pharmacological interventions such as virtual reality in reducing pain and medication use, and create tools for the early detection of neuropathy. Wireless, non-invasive neuroimaging methods, including functional near-infrared spectroscopy (fNIRS), will be used to support these objectives

Read the detailed description

PRIMARY OBJECTIVES:

  1. Develop an algorithm for objective evaluation of pain severity and distinguish the location of pain without needing patient cooperation.

II. Find the relationship between fNIRS (functional near-infrared spectroscopy) features and severity of pain as well as the relationship (if any) between perceived pain severity and psychological factors.

III. Understand the acute cold dysesthesias with oxaliplatin and how this correlated with more chronic neuropathy IV. Investigate the sustained effects of therapeutic virtual reality versus Sham virtual reality on pain severity and medication doses.

  1. Monitor VR-induced changes of brain activity to find out the underlying mechanisms of pain alleviation.

SECONDARY OBJECTIVES:

  1. Investigate the effect of demographic factors on perceived pain severity and VR-inducated pain alleviation
  • Investigate the effects of repeated VR use on doses of medications.

OUTLINE: Healthy participants are assigned to group A. Cancer patients are randomized to group B, C , D or E.

GROUP A: Participants undergo fNIRS for 10 minutes.

GROUP B: Patients undergo fNIRS for 10 minutes followed by a relaxation period using virtual reality (VR) for over 15 minutes.

GROUP C: Patients undergo fNIRS for 10 minutes.

GROUP D: Patients are randomized to 1 of 2 arm:

ARM I - Patients use VR for up to 30 minutes.

ARM II: Patients use Sham VR Program for up to 30 minutes

GROUP E: Cold pack stimulation on Day 1 of each chemotherapy cycle and day 3.

Being tested
Functional Near-Infrared Spectroscopy, Questionnaire Administration, Virtual Technology Intervention, Cold Stimulation
Medical subject headings
Breast Neoplasms, Carcinoma, Renal Cell, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Near-Infrared SpectroscopyProcedure or surgery

    Also called fNIRS, Functional Near Infrared Spectroscopy, Functional NIR Spectroscopy, Functional Optical Brain Imaging

    Undergo fNIRS

  • Questionnaire AdministrationOther

    Ancillary studies

  • Virtual Technology InterventionOther

    Also called Virtual Reality Intervention, Virtual Technology

    Undergo relaxation period using VR

  • Cold StimulationOther

    Also called ice pack

    cold stimulation using ice pack

Study groups in NCT06456411
Study groupRoleWhat they receive
Group A (fNIRS)ExperimentalParticipants undergo fNIRS for 10 minutes.
Receives: Procedure: Functional Near-Infrared Spectroscopy; Other: Questionnaire Administration
Group B (fNIRS, VR)ExperimentalPatients undergo fNIRS for 10 minutes followed by a relaxation period using VR for over 15 minutes.
Receives: Procedure: Functional Near-Infrared Spectroscopy; Other: Questionnaire Administration; Other: Virtual Technology Intervention
Group C (fNIRS)ExperimentalPatients undergo fNIRS for 10 minutes.
Receives: Procedure: Functional Near-Infrared Spectroscopy; Other: Questionnaire Administration
Group D Arm 1 - VRExperimentalPatients undergo Therapeutic VR program for up to 30 minutes four times per week
Receives: Other: Virtual Technology Intervention
Group D Arm II - Sham VRExperimentalPatients undergo placebo VR program for up to 30 minutes four times per week.
Receives: Other: Virtual Technology Intervention
Group EExperimentalCold stimulation on day 1 of each chemotherapy cycle and day 3.
Receives: Other: Cold Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gain knowledge of Brain activity during pain

    Computational neuroscience algorithms and graph theories will be used to extract informative patterns of brain activity and diagnose the stimulated brain areas associated with pain and pain severity as well as any relationships between pain severity, functional near-infrared spectroscopy (fNIRS) measures, and visual perception.

    Measured: Up to 16 months

Secondary outcomes (2)

  1. Determine if utilizing virtual reality technologies significantly alleviate pain through distraction

    By utilizing virtual reality relaxation program we will analyze brain activity to find out how this distraction is controlled by the brain.

    Measured: Up to 16 months

  2. Reason for pain alleviation caused by virtual reality techniques

    Measured by fNIRS and quantified by signal processing and network neuroscience algorithms, to find out the reason for pain alleviation caused by virtual reality techniques. We will also investigate if cognitive distraction can be the main reason.

    Measured: Up to 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start12 Jul 2022
  3. Primary completion10 Apr 2026
  4. Study completion10 Apr 2026

Why it stopped: PI left

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06456411
Sponsor's protocol ID
I 1720121
Other IDs
NCI-2021-11854, I 1720121
Status last verified
Apr 2026
First submitted
30 May 2024
Last updated
29 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Functional Near-Infrared Spectroscopy, Questionnaire Administration and Virtual Technology Intervention in people with Breast Carcinoma and Kidney Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: PI left). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gain knowledge of Brain activity during pain (time frame: Up to 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06456411.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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