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

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

Study Overview

• Status: Terminated
• Conditions: Carcinoma; Breast Carcinoma; Kidney Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Functional Near-Infrared Spectroscopy; Other: Virtual Technology Intervention; Other: Cold Stimulation

Detailed Description

PRIMARY OBJECTIVES:

I. 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.

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

SECONDARY OBJECTIVES:

I. 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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Study Population

Cancer patients with pain and healthy participants without pain.

Description

Inclusion Criteria: GROUPS A, B and C:

• 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

Inclusion Criteria - GROUP D:

• Men and women of 40-80 yrs old
• 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.

Inclusion criteria for Group E:

• 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.

Exclusion Criteria - GROUPS A, B and C:

• 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.
• 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

Exclusion criteria for Group D

• 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.

Exclusion Criteria for Group E

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group D Arm 1 - VR; Patients undergo Therapeutic VR program for up to 30 minutes four times per week	Other: Virtual Technology Intervention; Undergo relaxation period using VR; Other Names: Virtual Reality Intervention; Virtual Technology
Experimental: Group D Arm II - Sham VR; Patients undergo placebo VR program for up to 30 minutes four times per week.	Other: Virtual Technology Intervention; Undergo relaxation period using VR; Other Names: Virtual Reality Intervention; Virtual Technology
Experimental: Group E; Cold stimulation on day 1 of each chemotherapy cycle and day 3.	Other: Cold Stimulation; cold stimulation using ice pack; Other Names: ice pack
Experimental: Group A (fNIRS); Participants undergo fNIRS for 10 minutes.	Other: Questionnaire Administration; Ancillary studies; Procedure: Functional Near-Infrared Spectroscopy; Undergo fNIRS; Other Names: fNIRS; Functional Near Infrared Spectroscopy; Functional NIR Spectroscopy; Functional Optical Brain Imaging
Experimental: Group B (fNIRS, VR); Patients undergo fNIRS for 10 minutes followed by a relaxation period using VR for over 15 minutes.	Other: Questionnaire Administration; Ancillary studies; Procedure: Functional Near-Infrared Spectroscopy; Undergo fNIRS; Other Names: fNIRS; Functional Near Infrared Spectroscopy; Functional NIR Spectroscopy; Functional Optical Brain Imaging; Other: Virtual Technology Intervention; Undergo relaxation period using VR; Other Names: Virtual Reality Intervention; Virtual Technology
Experimental: Group C (fNIRS); Patients undergo fNIRS for 10 minutes.	Other: Questionnaire Administration; Ancillary studies; Procedure: Functional Near-Infrared Spectroscopy; Undergo fNIRS; Other Names: fNIRS; Functional Near Infrared Spectroscopy; Functional NIR Spectroscopy; Functional Optical Brain Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 16 months
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.	Up to 16 months

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Somayeh B Shafiei, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Actual): April 10, 2026
• Study Completion (Actual): April 10, 2026

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Skin Diseases; Breast Diseases; Urologic Neoplasms; Kidney Neoplasms; Skin and Connective Tissue Diseases; Carcinoma; Breast Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: I 1720121 (Other Identifier: Roswell Park Cancer Institute); NCI-2021-11854 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No