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

Recruiting

• Conditions: Breast Carcinoma; Kidney Carcinoma; Carcinoma

• Registration Number: NCT06456411
• Lead Sponsor: Roswell Park Cancer Institute

Brief 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. Wireless, non-invasive neuroimaging methods, including functional near-infrared spectroscopy (fNIRS), will be used to support these objectives

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. Investigate the sustained effects of therapeutic virtual reality versus Sham virtual reality on pain severity and medication doses.

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

V. Understand the acute cold dysesthesias with oxaliplatin and how this correlated with more chronic neuropathy

SECONDARY OBJECTIVES:

I. Monitor changes of brain activity to find out the reason for pain alleviation caused by virtual reality techniques and/or cognitive distraction.

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 over 15 minutes.

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

GROUP C: Patients undergo fNIRS for over 15 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 Timeline

• Study Start: 2022-07-12
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-07
• Study First Posted: 2024-06-13
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-25
• Primary Completion: 2026-07-12
• Study Completion: 2026-07-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

GROUPS A, B and C:

• Study participants in Group A, B or C (cancer patients as well as healthy volunteers) must be over the age of 18
• Study participants in Groups A, B or C (cancer patients as well as healthy volunteers) need to be able to be in a sedentary posture for approximately 20 minutes
• Study Participants in Group B and C: 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. Cancers include but are not limited to: breast, thoracic, lung, kidney, colon, pancreatic, etc.
• 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
• • 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

Inclusion Criteria - GROUP D:

• Men and women of 40-80 years 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.
• Must understand the investigational nature of the study and sign a written informed consent form approved by the Independent Ethics Committee/Institutional Review Board.
• 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

Inclusion criteria for Group E:

• Men and women aged 18 years 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.
• Participants must be free from other forms of chronic neuropathy
• Participants must be free from neurologic illnesses, e.g., stroke
• Had no brain metastases which could interfere with brain functions
• Diabetic patients will be excluded as those patients may experience different neuropathy and their reactions might skew the results.
• Participants must be willing to comply with study procedures.
• Participants 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

• Medical condition predisposing to nausea or dizziness.

• Hypersensitivity to flashing light or motion.

• No 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

  • Group B: Exclusion of 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.

• Group B: Exclusion of individuals with impaired stereoscopic vision or severe hearing impairments.

Exclusion criteria for Group D

• Exclusion of 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.
• Exclusion of 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.
• Exclusion of 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

• 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.
• Diabetic patients will be excluded as those patients may experience neuropathy differently.
• Females who are pregnant or plan to become pregnant during the study period will be excluded.
• Unwillingness or inability to follow protocol requirements.
• Exclusion of 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, uncontrolled diabetes, or peripheral neuropathy unrelated to chemotherapy.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gain knowledge of Brain activity during pain	Up to 16 months	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.

Secondary Outcome Measures

Name	Time	Method
Determine if utilizing virtual reality technologies significantly alleviate pain through distraction	Up to 16 months	By utilizing virtual reality relaxation program we will analyze brain activity to find out how this distraction is controlled by the brain.
Reason for pain alleviation caused by virtual reality techniques	Up to 16 months	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.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States